Study to Assess the Effect of Cannabidiol on Liver Fat Levels in Subjects With Fatty Liver Disease.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 
ClinicalTrials.gov Identifier: NCT01284634 
Recruitment Status :
Completed
First Posted : January 27, 2011
Results First Posted : January 20, 2014
Last Update Posted : September 18, 2014

Sponsor:
GW Research Ltd
Information provided by (Responsible Party):
GW Research Ltd
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Study Type:  Interventional 

Study Design:  Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment 
Condition: 
Fatty Liver 
Intervention: 
Drug: Cannabidiol 
Participant Flow
Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations 

No text entered. 
PreAssignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment 

No text entered. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Participant Flow: Overall Study
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

STARTED  7  6  7  5 
COMPLETED  6  6  5  4 
NOT COMPLETED  1  0  2  1 
Adverse Event  1  0  2  1 
Baseline Characteristics
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

No text entered. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first 30 minutes before breakfast [fasted] and the second 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003 per day. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 per day. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 per day. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Total  Total of all reporting groups 
Baseline Measures
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  Total  

Overall Participants Analyzed [Units: Participants] 
7  6  7  5  25  
Age [Units: Participants] 

<=18 years  0  0  0  0  0  
Between 18 and 65 years  6  6  7  5  24  
>=65 years  1  0  0  0  1  
Age [Units: Years] Mean (Standard Deviation) 
40.69 (14.62)  49.08 (7.72)  46.90 (12.57)  50.41 (18.41)  46.39 (13.29)  
Gender [Units: Participants] 

Female  5  2  2  4  13  
Male  2  4  5  1  12  
Region of Enrollment [Units: Participants] 

United Kingdom  7  6  7  5  25  
Outcome Measures
1. Primary:  Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels [ Time Frame: After 56 days of treatment ] 
Measure Type  Primary 

Measure Title  Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels 
Measure Description  Liver triglyceride levels (%) were measured by MRI/MRS scanning and the change from baseline to end of treatment in group mean levels were investigated. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  6  5 
Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels [Units: Percentage of liver triglycerides] Mean (Standard Deviation) 
0.68 (4.97)  0.28 (8.60)  0.65 (5.28)  6.36 (17.97) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.222 
Mean Difference (Final Values) ^{[5]}  6.89 
90% Confidence Interval  16.35 to 2.56 
Standard Error of the mean  (5.454) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment liver triglyceride levels were analysed using a linear regression model, with end of treatment liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.133 
Mean Difference (Final Values) ^{[5]}  9.35 
90% Confidence Interval  19.66 to 0.95 
Standard Error of the mean  (5.943) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment liver triglyceride levels were analysed using a linear regression model, with end of treatment liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.302 
Mean Difference (Final Values) ^{[5]}  6.54 
90% Confidence Interval  17.22 to 4.14 
Standard Error of the mean  (6.158) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment liver triglyceride levels were analysed using a linear regression model, with end of treatment liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
2. Secondary:  Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels 
Measure Description  A fasting blood sample was taken for the measurement of serum total cholesterol. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 . 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels [Units: Mmol/l] Mean (Standard Deviation) 
0.07 (0.76)  0.03 (0.51)  0.14 (0.31)  0.62 (1.00) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.201 
Mean Difference (Final Values) ^{[5]}  0.51 
90% Confidence Interval  0.16 to 1.18 
Standard Error of the mean  (0.386) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum total cholesterol levels were analysed using a linear regression model, with end of treatment serum total cholesterol levels as the dependent variable, dose of GWP42003 as regressor, baseline serum total cholesterol levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.397 
Mean Difference (Final Values) ^{[5]}  0.36 
90% Confidence Interval  0.35 to 1.07 
Standard Error of the mean  (0.411) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum total cholesterol levels were analysed using a linear regression model, with end of treatment serum total cholesterol levels as the dependent variable, dose of GWP42003 as regressor, baseline serum total cholesterol levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.927 
Mean Difference (Final Values) ^{[5]}  0.04 
90% Confidence Interval  0.70 to 0.78 
Standard Error of the mean  (0.428) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum total cholesterol levels were analysed using a linear regression model, with end of treatment serum total cholesterol levels as the dependent variable, dose of GWP42003 as regressor, baseline serum total cholesterol levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
3. Secondary:  Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)Cholesterol(C) Levels [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)Cholesterol(C) Levels 
Measure Description  A fasting blood sample was obtained for the measurement of HDLC. An increase from baseline (i.e. a positive value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)Cholesterol(C) Levels [Units: Mmol/l] Mean (Standard Deviation) 
0.07 (0.15)  0.08 (0.15)  0.06 (0.17)  0.14 (0.23) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)Cholesterol(C) Levels
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.186 
Mean Difference (Final Values) ^{[5]}  0.14 
90% Confidence Interval  0.04 to 0.31 
Standard Error of the mean  (0.101) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum HDLC levels were analysed using a linear regression model, with end of treatment serum HDLC levels as the dependent variable, dose of GWP42003 as regressor, baseline HDLC levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)Cholesterol(C) Levels
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.145 
Mean Difference (Final Values) ^{[5]}  0.16 
90% Confidence Interval  0.02 to 0.35 
Standard Error of the mean  (0.107) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum HDLC levels were analysed using a linear regression model, with end of treatment serum HDLC levels as the dependent variable, dose of GWP42003 as regressor, baseline HDLC levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)Cholesterol(C) Levels
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.304 
Mean Difference (Final Values) ^{[5]}  0.11 
90% Confidence Interval  0.07 to 0.30 
Standard Error of the mean  (0.108) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum HDLC levels were analysed using a linear regression model, with end of treatment serum HDLC levels as the dependent variable, dose of GWP42003 as regressor, baseline HDLC levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
4. Secondary:  Change From Baseline to the End of Treatment in Mean Serum Low Density Lipoprotein (LDL)Cholesterol(C) Levels [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Serum Low Density Lipoprotein (LDL)Cholesterol(C) Levels 
Measure Description  A fasting blood sample was obtained for the measurement of LDLC. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment in Mean Serum Low Density Lipoprotein (LDL)Cholesterol(C) Levels [Units: Mmol/l] Mean (Standard Deviation) 
0.11 (0.63)  0.08 (0.41)  0.00 (0.43)  0.34 (0.74) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Serum Low Density Lipoprotein (LDL)Cholesterol(C) Levels
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.302 
Mean Difference (Final Values) ^{[5]}  0.31 
90% Confidence Interval  0.19 to 0.81 
Standard Error of the mean  (0.289) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum LDLC levels were analysed using a linear regression model, with end of treatment serum LDLC levels as the dependent variable, dose of GWP42003 as regressor, baseline LDLC levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Serum Low Density Lipoprotein (LDL)Cholesterol(C) Levels
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.564 
Mean Difference (Final Values) ^{[5]}  0.18 
90% Confidence Interval  0.35 to 0.71 
Standard Error of the mean  (0.308) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum LDLC levels were analysed using a linear regression model, with end of treatment serum LDLC levels as the dependent variable, dose of GWP42003 as regressor, baseline LDLC levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Serum Low Density Lipoprotein (LDL)Cholesterol(C) Levels
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.874 
Mean Difference (Final Values) ^{[5]}  0.05 
90% Confidence Interval  0.58 to 0.49 
Standard Error of the mean  (0.309) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum LDLC levels were analysed using a linear regression model, with end of treatment serum LDLC levels as the dependent variable, dose of GWP42003 as regressor, baseline LDLC levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
5. Secondary:  Change From Baseline to the End of Treatment it the Mean Serum HDL:LDL Cholesterol Ratio [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment it the Mean Serum HDL:LDL Cholesterol Ratio 
Measure Description  A fasting blood sample was obtained for the measurement of HDLC and LDLC, allowing the HDL:LDL cholesterol ratio to be calculated. An increase from baseline (i.e. a positive value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment it the Mean Serum HDL:LDL Cholesterol Ratio [Units: Ratio] Mean (Standard Deviation) 
0.02 (0.13)  0.00 (0.08)  0.03 (0.09)  0.01 (0.06) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment it the Mean Serum HDL:LDL Cholesterol Ratio
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.703 
Mean Difference (Final Values) ^{[5]}  0.01 
90% Confidence Interval  0.07 to 0.05 
Standard Error of the mean  (0.035) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum serum HDL:LDL cholesterol ratio was analysed using a linear regression model, with end of treatment serum HDL:LDL cholesterol ratio as the dependent variable, dose of GWP42003 as regressor, baseline serum HDL:LDL cholesterol ratio as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment it the Mean Serum HDL:LDL Cholesterol Ratio
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.532 
Mean Difference (Final Values) ^{[5]}  0.02 
90% Confidence Interval  0.04 to 0.09 
Standard Error of the mean  (0.039) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum serum HDL:LDL cholesterol ratio was analysed using a linear regression model, with end of treatment serum HDL:LDL cholesterol ratio as the dependent variable, dose of GWP42003 as regressor, baseline serum HDL:LDL cholesterol ratio as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment it the Mean Serum HDL:LDL Cholesterol Ratio
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.087 
Mean Difference (Final Values) ^{[5]}  0.07 
90% Confidence Interval  0.00 to 0.13 
Standard Error of the mean  (0.038) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum serum HDL:LDL cholesterol ratio was analysed using a linear regression model, with end of treatment serum HDL:LDL cholesterol ratio as the dependent variable, dose of GWP42003 as regressor, baseline serum HDL:LDL cholesterol ratio as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
6. Secondary:  Change From Baseline to the End of Treatment in Mean Serum Triglyceride Levels [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Serum Triglyceride Levels 
Measure Description  A fasting blood sample was obtained for the measurement of serum triglycerides. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment in Mean Serum Triglyceride Levels [Units: Mmol/l] Mean (Standard Deviation) 
0.40 (1.05)  0.29 (0.82)  0.50 (1.16)  0.28 (0.39) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Serum Triglyceride Levels
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.556 
Mean Difference (Final Values) ^{[5]}  0.22 
90% Confidence Interval  0.42 to 0.87 
Standard Error of the mean  (0.374) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum triglyceride levels were analysed using a linear regression model, with end of treatment serum triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline serum triglyceride levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Serum Triglyceride Levels
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.458 
Mean Difference (Final Values) ^{[5]}  0.31 
90% Confidence Interval  1.02 to 0.40 
Standard Error of the mean  (0.409) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum triglyceride levels were analysed using a linear regression model, with end of treatment serum triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline serum triglyceride levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Serum Triglyceride Levels
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.868 
Mean Difference (Final Values) ^{[5]}  0.07 
90% Confidence Interval  0.75 to 0.62 
Standard Error of the mean  (0.395) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum triglyceride levels were analysed using a linear regression model, with end of treatment serum triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline serum triglyceride levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
7. Secondary:  Change From Baseline to the End of Treatment in Mean Fasting Plasma Glucose Levels [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Fasting Plasma Glucose Levels 
Measure Description  A fasting blood sample was obtained for the measurement of fasting plasma glucose. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 . 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  4 
Change From Baseline to the End of Treatment in Mean Fasting Plasma Glucose Levels [Units: Mmol/l] Mean (Standard Deviation) 
0.01 (0.35)  0.20 (0.28)  0.10 (0.35)  0.13 (0.49) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Fasting Plasma Glucose Levels
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.602 
Mean Difference (Final Values) ^{[5]}  0.10 
90% Confidence Interval  0.22 to 0.41 
Standard Error of the mean  (0.181) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fasting plasma glucose levels were analysed using a linear regression model, with end of treatment fasting plasma glucose levels as the dependent variable, dose of GWP42003 as regressor, baseline fasting plasma glucose levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Fasting Plasma Glucose Levels
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.380 
Mean Difference (Final Values) ^{[5]}  0.18 
90% Confidence Interval  0.16 to 0.52 
Standard Error of the mean  (0.195) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fasting plasma glucose levels were analysed using a linear regression model, with end of treatment fasting plasma glucose levels as the dependent variable, dose of GWP42003 as regressor, baseline fasting plasma glucose levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Fasting Plasma Glucose Levels
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.832 
Mean Difference (Final Values) ^{[5]}  0.04 
90% Confidence Interval  0.29 to 0.38 
Standard Error of the mean  (0.193) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fasting plasma glucose levels were analysed using a linear regression model, with end of treatment fasting plasma glucose levels as the dependent variable, dose of GWP42003 as regressor, baseline fasting plasma glucose levels as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
8. Secondary:  Change From Baseline to the End of Treatment in Mean Body Mass Index (BMI) [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Body Mass Index (BMI) 
Measure Description  Individual subject's BMIs were calculated by dividing mass (kg) by height (m2). A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment in Mean Body Mass Index (BMI) [Units: Kg/m2] Mean (Standard Deviation) 
0.11 (0.24)  0.31 (0.34)  0.10 (0.25)  0.38 (1.28) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Body Mass Index (BMI)
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.351 
Mean Difference (Final Values) ^{[5]}  0.35 
90% Confidence Interval  0.29 to 1.00 
Standard Error of the mean  (0.371) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment BMIs were analysed using a linear regression model, with end of treatment BMI as the dependent variable, dose of GWP42003 as regressor, baseline BMI as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Body Mass Index (BMI)
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.185 
Mean Difference (Final Values) ^{[5]}  0.53 
90% Confidence Interval  0.14 to 1.20 
Standard Error of the mean  (0.388) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment BMIs were analysed using a linear regression model, with end of treatment BMI as the dependent variable, dose of GWP42003 as regressor, baseline BMI as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Body Mass Index (BMI)
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.685 
Mean Difference (Final Values) ^{[5]}  0.16 
90% Confidence Interval  0.50 to 0.82 
Standard Error of the mean  (0.383) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment BMIs were analysed using a linear regression model, with end of treatment BMI as the dependent variable, dose of GWP42003 as regressor, baseline BMI as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
9. Secondary:  Change From Baseline to the End of Treatment in Mean Body Weight [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Body Weight 
Measure Description  Body weight (kg) was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment in Mean Body Weight [Units: Kg] Mean (Standard Deviation) 
0.33 (0.68)  0.95 (1.02)  0.24 (0.67)  1.00 (3.27) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Body Weight
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.319 
Mean Difference (Final Values) ^{[5]}  0.94 
90% Confidence Interval  0.65 to 2.54 
Standard Error of the mean  (0.923) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment body weight measurements were analysed using a linear regression model, with end of treatment body weight as the dependent variable, dose of GWP42003 as regressor, baseline body weight as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Body Weight
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.145 
Mean Difference (Final Values) ^{[5]}  1.49 
90% Confidence Interval  0.20 to 3.19 
Standard Error of the mean  (0.980) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment body weight measurements were analysed using a linear regression model, with end of treatment body weight as the dependent variable, dose of GWP42003 as regressor, baseline body weight as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Body Weight
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.562 
Mean Difference (Final Values) ^{[5]}  0.58 
90% Confidence Interval  1.12 to 2.29 
Standard Error of the mean  (0.986) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment body weight measurements were analysed using a linear regression model, with end of treatment body weight as the dependent variable, dose of GWP42003 as regressor, baseline body weight as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
10. Secondary:  Change From Baseline to the End of Treatment in Mean Waisttohip Ratio [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Waisttohip Ratio 
Measure Description  The waisttohip ratio was calculated at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment in Mean Waisttohip Ratio [Units: Ratio] Mean (Standard Deviation) 
0.02 (0.08)  0.01 (0.06)  0.01 (0.02)  0.00 (0.01) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Waisttohip Ratio
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.386 
Mean Difference (Final Values) ^{[5]}  0.016 
90% Confidence Interval  0.048 to 0.015 
Standard Error of the mean  (0.018) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment waisttohip ratio was analysed using a linear regression model, with end of treatment waisttohip ratio as the dependent variable, dose of GWP42003 as regressor, baseline waisttohip ratio as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Waisttohip Ratio
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.968 
Mean Difference (Final Values) ^{[5]}  0.001 
90% Confidence Interval  0.034 to 0.035 
Standard Error of the mean  (0.020) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment waisttohip ratio was analysed using a linear regression model, with end of treatment waisttohip ratio as the dependent variable, dose of GWP42003 as regressor, baseline waisttohip ratio as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Waisttohip Ratio
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.193 
Mean Difference (Final Values) ^{[5]}  0.027 
90% Confidence Interval  0.061 to 0.008 
Standard Error of the mean  (0.020) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment waisttohip ratio was analysed using a linear regression model, with end of treatment waisttohip ratio as the dependent variable, dose of GWP42003 as regressor, baseline waisttohip ratio as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
11. Secondary:  Change From Baseline to the End of Treatment in Mean Neck Measurement [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Neck Measurement 
Measure Description  The neck circumference was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment in Mean Neck Measurement [Units: Cm] Mean (Standard Deviation) 
1.21 (3.66)  2.65 (3.18)  0.44 (0.86)  1.24 (1.42) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Neck Measurement
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.334 
Mean Difference (Final Values) ^{[5]}  1.68 
90% Confidence Interval  4.62 to 1.25 
Standard Error of the mean  (1.697) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment neck measurement was analysed using a linear regression model, with end of treatment neck measurement as the dependent variable, dose of GWP42003 as regressor, baseline neck measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Neck Measurement
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.109 
Mean Difference (Final Values) ^{[5]}  3.13 
90% Confidence Interval  6.35 to 0.09 
Standard Error of the mean  (1.862) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment neck measurement was analysed using a linear regression model, with end of treatment neck measurement as the dependent variable, dose of GWP42003 as regressor, baseline neck measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Neck Measurement
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.539 
Mean Difference (Final Values) ^{[5]}  1.11 
90% Confidence Interval  4.18 to 1.96 
Standard Error of the mean  (1.776) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment neck measurement was analysed using a linear regression model, with end of treatment neck measurement as the dependent variable, dose of GWP42003 as regressor, baseline neck measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
12. Secondary:  Change From Baseline to the End of Treatment in Mean Waist Measurement [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Waist Measurement 
Measure Description  Waist circumference was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment in Mean Waist Measurement [Units: Cm] Mean (Standard Deviation) 
4.29 (8.24)  1.20 (5.94)  1.44 (2.76)  2.58 (4.38) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Waist Measurement
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.613 
Mean Difference (Final Values) ^{[5]}  1.53 
90% Confidence Interval  6.68 to 3.62 
Standard Error of the mean  (2.980) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment waist measurement was analysed using a linear regression model, with end of treatment waist measurement as the dependent variable, dose of GWP42003 as regressor, baseline waist measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Waist Measurement
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.965 
Mean Difference (Final Values) ^{[5]}  0.15 
90% Confidence Interval  5.54 to 5.83 
Standard Error of the mean  (3.286) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment waist measurement was analysed using a linear regression model, with end of treatment waist measurement as the dependent variable, dose of GWP42003 as regressor, baseline waist measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Waist Measurement
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.550 
Mean Difference (Final Values) ^{[5]}  2.07 
90% Confidence Interval  7.94 to 3.81 
Standard Error of the mean  (3.396) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment waist measurement was analysed using a linear regression model, with end of treatment waist measurement as the dependent variable, dose of GWP42003 as regressor, baseline waist measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
13. Secondary:  Change From Baseline to the End of Treatment in Mean Hip Measurement [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Hip Measurement 
Measure Description  Hip circumference was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment in Mean Hip Measurement [Units: Cm] Mean (Standard Deviation) 
2.74 (6.04)  0.38 (3.47)  0.39 (1.31)  3.28 (5.45) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Hip Measurement
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.906 
Mean Difference (Final Values) ^{[5]}  0.30 
90% Confidence Interval  4.04 to 4.65 
Standard Error of the mean  (2.513) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment hip measurement was analysed using a linear regression model, with end of treatment hip measurement as the dependent variable, dose of GWP42003 as regressor, baseline hip measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Hip Measurement
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.666 
Mean Difference (Final Values) ^{[5]}  1.22 
90% Confidence Interval  3.60 to 6.04 
Standard Error of the mean  (2.787) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment hip measurement was analysed using a linear regression model, with end of treatment hip measurement as the dependent variable, dose of GWP42003 as regressor, baseline hip measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Hip Measurement
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.722 
Mean Difference (Final Values) ^{[5]}  1.00 
90% Confidence Interval  3.77 to 5.76 
Standard Error of the mean  (2.755) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment hip measurement was analysed using a linear regression model, with end of treatment hip measurement as the dependent variable, dose of GWP42003 as regressor, baseline hip measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
14. Secondary:  Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Chest/Pectoral) [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Chest/Pectoral) 
Measure Description  Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Chest/Pectoral) [Units: Mm] Mean (Standard Deviation) 
8.30 (15.69)  4.12 (15.34)  5.26 (12.25)  5.86 (10.18) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Chest/Pectoral)
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.494 
Mean Difference (Final Values) ^{[5]}  5.67 
90% Confidence Interval  8.38 to 19.73 
Standard Error of the mean  (8.130) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Chest/Pectoral)
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.613 
Mean Difference (Final Values) ^{[5]}  4.67 
90% Confidence Interval  11.01 to 20.34 
Standard Error of the mean  (9.066) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Chest/Pectoral)
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.541 
Mean Difference (Final Values) ^{[5]}  5.49 
90% Confidence Interval  9.75 to 20.73 
Standard Error of the mean  (8.813) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
15. Secondary:  Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Midaxillary) [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Midaxillary) 
Measure Description  Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Midaxillary) [Units: Mm] Mean (Standard Deviation) 
1.8 (10.10)  2.4 (9.30)  3.8 (10.69)  6.1 (4.16) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Midaxillary)
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.858 
Mean Difference (Final Values) ^{[5]}  1.00 
90% Confidence Interval  10.58 to 8.57 
Standard Error of the mean  (5.536) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Midaxillary)
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.855 
Mean Difference (Final Values) ^{[5]}  1.08 
90% Confidence Interval  9.00 to 11.15 
Standard Error of the mean  (5.826) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Midaxillary)
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.660 
Mean Difference (Final Values) ^{[5]}  2.55 
90% Confidence Interval  7.31 to 12.40 
Standard Error of the mean  (5.700) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
16. Secondary:  Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Triceps) [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Triceps) 
Measure Description  Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Triceps) [Units: Mm] Mean (Standard Deviation) 
1.9 (8.26)  4.0 (9.32)  0.7 (13.32)  4.0 (12.33) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Triceps)
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.768 
Mean Difference (Final Values) ^{[5]}  2.09 
90% Confidence Interval  9.99 to 14.17 
Standard Error of the mean  (6.987) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Triceps)
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.534 
Mean Difference (Final Values) ^{[5]}  4.68 
90% Confidence Interval  8.10 to 17.47 
Standard Error of the mean  (7.393) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Triceps)
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.875 
Mean Difference (Final Values) ^{[5]}  1.21 
90% Confidence Interval  11.89 to 14.31 
Standard Error of the mean  (7.579) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
17. Secondary:  Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Subscapular) [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Subscapular) 
Measure Description  Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Subscapular) [Units: Mm] Mean (Standard Deviation) 
3.0 (5.70)  0.6 (7.30)  3.7 (9.15)  4.0 (9.48) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Subscapular)
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.971 
Mean Difference (Final Values) ^{[5]}  0.20 
90% Confidence Interval  9.44 to 9.04 
Standard Error of the mean  (5.344) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Subscapular)
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.794 
Mean Difference (Final Values) ^{[5]}  1.49 
90% Confidence Interval  11.26 to 8.28 
Standard Error of the mean  (5.650) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Subscapular)
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.753 
Mean Difference (Final Values) ^{[5]}  1.77 
90% Confidence Interval  7.82 to 11.37 
Standard Error of the mean  (5.547) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
18. Secondary:  Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Abdomen) [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Abdomen) 
Measure Description  Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Abdomen) [Units: Mm] Mean (Standard Deviation) 
1.3 (9.21)  4.6 (12.59)  5.2 (12.35)  4.2 (11.13) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Abdomen)
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.830 
Mean Difference (Final Values) ^{[5]}  1.54 
90% Confidence Interval  13.77 to 10.70 
Standard Error of the mean  (7.075) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Abdomen)
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.946 
Mean Difference (Final Values) ^{[5]}  0.52 
90% Confidence Interval  12.66 to 13.71 
Standard Error of the mean  (7.626) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Abdomen)
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.901 
Mean Difference (Final Values) ^{[5]}  0.94 
90% Confidence Interval  11.99 to 13.86 
Standard Error of the mean  (7.475) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
19. Secondary:  Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Suprailiac) [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Suprailiac) 
Measure Description  Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Suprailiac) [Units: Mm] Mean (Standard Deviation) 
3.6 (8.16)  6.8 (11.38)  5.2 (8.27)  2.0 (11.03) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Suprailiac)
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.704 
Mean Difference (Final Values) ^{[5]}  2.30 
90% Confidence Interval  7.99 to 12.59 
Standard Error of the mean  (5.952) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Suprailiac)
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.365 
Mean Difference (Final Values) ^{[5]}  5.99 
90% Confidence Interval  5.18 to 17.16 
Standard Error of the mean  (6.458) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Suprailiac)
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.493 
Mean Difference (Final Values) ^{[5]}  4.44 
90% Confidence Interval  6.53 to 15.40 
Standard Error of the mean  (6.339) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
20. Secondary:  Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Thigh) [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Thigh) 
Measure Description  Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Thigh) [Units: Mm] Mean (Standard Deviation) 
4.2 (11.77)  6.1 (13.77)  1.6 (10.47)  3.7 (6.13) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Thigh)
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.679 
Mean Difference (Final Values) ^{[5]}  2.61 
90% Confidence Interval  13.39 to 8.16 
Standard Error of the mean  (6.230) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Thigh)
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.424 
Mean Difference (Final Values) ^{[5]}  5.32 
90% Confidence Interval  5.94 to 16.59 
Standard Error of the mean  (6.516) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skinfold Thickness (Thigh)
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.801 
Mean Difference (Final Values) ^{[5]}  1.65 
90% Confidence Interval  9.52 to 12.82 
Standard Error of the mean  (6.460) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
21. Secondary:  Change From Baseline to the End of Treatment in Mean Total Skinfold Thickness [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Total Skinfold Thickness 
Measure Description  Total skin fold thickness was based on the sum of the average values from the seven sites stated above. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  7  5 
Change From Baseline to the End of Treatment in Mean Total Skinfold Thickness [Units: Mm] Mean (Standard Deviation) 
15.7 (56.76)  28.6 (70.03)  24.1 (57.09)  29.7 (54.58) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Total Skinfold Thickness
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.954 
Mean Difference (Final Values) ^{[5]}  2.23 
90% Confidence Interval  68.68 to 64.22 
Standard Error of the mean  (38.430) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Total Skinfold Thickness
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.716 
Mean Difference (Final Values) ^{[5]}  15.12 
90% Confidence Interval  55.69 to 85.93 
Standard Error of the mean  (40.950) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Total Skinfold Thickness
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.776 
Mean Difference (Final Values) ^{[5]}  11.66 
90% Confidence Interval  58.18 to 81.49 
Standard Error of the mean  (40.387) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
22. Secondary:  Change From Baseline to the End of Treatment in Mean Visceral Abdominal Fat [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Visceral Abdominal Fat 
Measure Description  As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  6  5 
Change From Baseline to the End of Treatment in Mean Visceral Abdominal Fat [Units: Litres] Mean (Standard Deviation) 
0.21 (0.41)  0.06 (0.22)  0.25 (1.08)  0.77 (1.96) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Visceral Abdominal Fat
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.091 
Mean Difference (Final Values) ^{[5]}  1.03 
90% Confidence Interval  0.03 to 2.04 
Standard Error of the mean  (0.579) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Visceral Abdominal Fat
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.087 
Mean Difference (Final Values) ^{[5]}  1.16 
90% Confidence Interval  0.05 to 2.28 
Standard Error of the mean  (0.642) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Visceral Abdominal Fat
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.063 
Mean Difference (Final Values) ^{[5]}  1.25 
90% Confidence Interval  0.16 to 2.35 
Standard Error of the mean  (0.633) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
23. Secondary:  Change From Baseline to the End of Treatment in Mean Subcutaneous Abdominal Fat [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Subcutaneous Abdominal Fat 
Measure Description  As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  6  5 
Change From Baseline to the End of Treatment in Mean Subcutaneous Abdominal Fat [Units: Litres] Mean (Standard Deviation) 
1.24 (3.01)  0.13 (0.21)  0.01 (0.57)  0.83 (2.19) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Subcutaneous Abdominal Fat
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.077 
Mean Difference (Final Values) ^{[5]}  2.31 
90% Confidence Interval  0.17 to 4.44 
Standard Error of the mean  (1.229) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Subcutaneous Abdominal Fat
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.406 
Mean Difference (Final Values) ^{[5]}  1.11 
90% Confidence Interval  1.14 to 3.35 
Standard Error of the mean  (1.297) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Subcutaneous Abdominal Fat
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.532 
Mean Difference (Final Values) ^{[5]}  0.83 
90% Confidence Interval  1.42 to 3.08 
Standard Error of the mean  (1.299) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
24. Secondary:  Change From Baseline to the End of Treatment in Mean Total Abdominal Fat [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Total Abdominal Fat 
Measure Description  As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  6  5 
Change From Baseline to the End of Treatment in Mean Total Abdominal Fat [Units: Litres] Mean (Standard Deviation) 
1.44 (3.23)  0.07 (0.40)  0.24 (1.55)  1.60 (2.91) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Total Abdominal Fat
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.025 
Mean Difference (Final Values) ^{[5]}  3.45 
90% Confidence Interval  1.00 to 5.91 
Standard Error of the mean  (1.415) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Total Abdominal Fat
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.165 
Mean Difference (Final Values) ^{[5]}  2.20 
90% Confidence Interval  0.44 to 4.84 
Standard Error of the mean  (1.522) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Total Abdominal Fat
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.194 
Mean Difference (Final Values) ^{[5]}  2.04 
90% Confidence Interval  0.58 to 4.67 
Standard Error of the mean  (1.514) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
25. Secondary:  Change From Baseline to the End of Treatment in Mean Internal Nonabdominal Fat [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Internal Nonabdominal Fat 
Measure Description  As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  6  5 
Change From Baseline to the End of Treatment in Mean Internal Nonabdominal Fat [Units: Litres] Mean (Standard Deviation) 
0.07 (0.42)  0.06 (0.33)  0.01 (0.64)  0.02 (0.75) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Internal Nonabdominal Fat
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.700 
Mean Difference (Final Values) ^{[5]}  0.13 
90% Confidence Interval  0.44 to 0.69 
Standard Error of the mean  (0.325) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Internal Nonabdominal Fat
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.958 
Mean Difference (Final Values) ^{[5]}  0.02 
90% Confidence Interval  0.59 to 0.63 
Standard Error of the mean  (0.352) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Internal Nonabdominal Fat
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.777 
Mean Difference (Final Values) ^{[5]}  0.10 
90% Confidence Interval  0.72 to 0.52 
Standard Error of the mean  (0.356) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
26. Secondary:  Change From Baseline to the End of Treatment in Mean Subcutaneous Nonabdominal Fat [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Subcutaneous Nonabdominal Fat 
Measure Description  As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  6  5 
Change From Baseline to the End of Treatment in Mean Subcutaneous Nonabdominal Fat [Units: Litres] Mean (Standard Deviation) 
0.74 (2.86)  0.06 (0.46)  0.13 (0.62)  0.17 (1.65) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Subcutaneous Nonabdominal Fat
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.409 
Mean Difference (Final Values) ^{[5]}  0.86 
90% Confidence Interval  2.63 to 0.90 
Standard Error of the mean  (1.018) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Subcutaneous Nonabdominal Fat
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.485 
Mean Difference (Final Values) ^{[5]}  0.80 
90% Confidence Interval  2.76 to 1.15 
Standard Error of the mean  (1.126) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Subcutaneous Nonabdominal Fat
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.429 
Mean Difference (Final Values) ^{[5]}  0.94 
90% Confidence Interval  2.96 to 1.08 
Standard Error of the mean  (1.165) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
27. Secondary:  Change From Baseline to the End of Treatment in Mean Total Nonabdominal Fat [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Total Nonabdominal Fat 
Measure Description  As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  6  5 
Change From Baseline to the End of Treatment in Mean Total Nonabdominal Fat [Units: Litres] Mean (Standard Deviation) 
0.67 (3.15)  0.13 (0.75)  0.15 (1.10)  0.15 (2.29) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Total Nonabdominal Fat
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.542 
Mean Difference (Final Values) ^{[5]}  0.76 
90% Confidence Interval  2.90 to 1.37 
Standard Error of the mean  (1.229) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Total Nonabdominal Fat
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.584 
Mean Difference (Final Values) ^{[5]}  0.76 
90% Confidence Interval  3.10 to 1.59 
Standard Error of the mean  (1.353) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Total Nonabdominal Fat
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.499 
Mean Difference (Final Values) ^{[5]}  0.97 
90% Confidence Interval  3.40 to 1.46 
Standard Error of the mean  (1.401) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
28. Secondary:  Change From Baseline to the End of Treatment in Mean Total Internal Fat [ Time Frame: After 56 days of treatment ] 
Measure Type  Secondary 

Measure Title  Change From Baseline to the End of Treatment in Mean Total Internal Fat 
Measure Description  As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. 
Time Frame  After 56 days of treatment 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. 
Reporting Groups
Description  

200 mg GWP42003  Subjects selfadministered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003. 
400 mg GWP42003  Subjects selfadministered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003. 
800 mg GWP42003  Subjects selfadministered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003. 
Placebo  Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects selfadministered one, two or four placebo capsules twice daily, according to the same regimen as active treatment. 
Measured Values
200 mg GWP42003  400 mg GWP42003  800 mg GWP42003  Placebo  

Participants Analyzed  7  6  6  5 
Change From Baseline to the End of Treatment in Mean Total Internal Fat [Units: Litres] Mean (Standard Deviation) 
0.28 (0.65)  0.01 (0.53)  0.26 (1.69)  0.80 (2.61) 
Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Total Internal Fat
Groups ^{[1]}  200 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.191 
Mean Difference (Final Values) ^{[5]}  1.19 
90% Confidence Interval  0.33 to 2.71 
Standard Error of the mean  (0.875) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Total Internal Fat
Groups ^{[1]}  400 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.246 
Mean Difference (Final Values) ^{[5]}  1.16 
90% Confidence Interval  0.51 to 2.83 
Standard Error of the mean  (0.963) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

All statistical tests were twosided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Total Internal Fat
Groups ^{[1]}  800 mg GWP42003 vs. Placebo 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.261 
Mean Difference (Final Values) ^{[5]}  1.11 
90% Confidence Interval 