# Study to Assess the Effect of Cannabidiol on Liver Fat Levels in Subjects With Fatty Liver Disease.

This study has been completed.

Sponsor:

GW Research Ltd

Information provided by (Responsible Party):

GW Research Ltd

ClinicalTrials.gov Identifier:

NCT01284634

First received: January 26, 2011

Last updated: September 9, 2014

Last verified: September 2014

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Results First Received: December 3, 2013

Study Type: | Interventional |
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Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, 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 |
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No text entered. |

Pre-Assignment Details

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

Reporting Groups

Description | |
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200 mg GWP42003 | Subjects self-administered 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 self-administered 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 self-administered 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 self-administered 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 | |
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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. |
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No text entered. |

Reporting Groups

Description | |
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200 mg GWP42003 | Subjects self-administered 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 self-administered 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 self-administered 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 self-administered 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Overall Participants Analyzed [Units: Participants] |
7 | 6 | 7 | 5 | 25 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||

Age [Units: Participants] |
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<=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] |
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Region of Enrollment [Units: Participants] |
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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 self-administered 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 self-administered 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 self-administered 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 self-administered 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 [Units: Participants] |
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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | Additional information, such as whether or not the p-value 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 two-sided 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 non-inferiority 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 p-value 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 two-sided 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 non-inferiority 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 p-value 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 self-administered 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 self-administered 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 self-administered 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 |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

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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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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 HDL-C. An increase from baseline (i.e. a positive value) indicates an improvement in condition. |

Time Frame | After 56 days of treatment |

Population Description

All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group. |

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | Subjects self-administered 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 |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
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 two-sided 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 HDL-C levels were analysed using a linear regression model, with end of treatment serum HDL-C levels as the dependent variable, dose of GWP42003 as regressor, baseline HDL-C levels as a covariate, and gender as a factor. | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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 two-sided 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 HDL-C levels were analysed using a linear regression model, with end of treatment serum HDL-C levels as the dependent variable, dose of GWP42003 as regressor, baseline HDL-C levels as a covariate, and gender as a factor. | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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 two-sided 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 HDL-C levels were analysed using a linear regression model, with end of treatment serum HDL-C levels as the dependent variable, dose of GWP42003 as regressor, baseline HDL-C levels as a covariate, and gender as a factor. | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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 LDL-C. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. |

Time Frame | After 56 days of treatment |

Population Description

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
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 two-sided 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 LDL-C levels were analysed using a linear regression model, with end of treatment serum LDL-C levels as the dependent variable, dose of GWP42003 as regressor, baseline LDL-C levels as a covariate, and gender as a factor. | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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 two-sided 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 LDL-C levels were analysed using a linear regression model, with end of treatment serum LDL-C levels as the dependent variable, dose of GWP42003 as regressor, baseline LDL-C levels as a covariate, and gender as a factor. | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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 two-sided 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 LDL-C levels were analysed using a linear regression model, with end of treatment serum LDL-C levels as the dependent variable, dose of GWP42003 as regressor, baseline LDL-C levels as a covariate, and gender as a factor. | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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 HDL-C and LDL-C, 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

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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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

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

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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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

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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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

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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

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | Subjects self-administered 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 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

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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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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[5] | Other relevant estimation information: |

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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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

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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

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

10. Secondary: | Change From Baseline to the End of Treatment in Mean Waist-to-hip Ratio [ Time Frame: After 56 days of treatment ] |

Measure Type | Secondary |
---|---|

Measure Title | Change From Baseline to the End of Treatment in Mean Waist-to-hip Ratio |

Measure Description | The waist-to-hip 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

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
7 | 6 | 7 | 5 |

Change From Baseline to the End of Treatment in Mean Waist-to-hip 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 Waist-to-hip 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 two-sided 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-to-hip ratio was analysed using a linear regression model, with end of treatment waist-to-hip ratio as the dependent variable, dose of GWP42003 as regressor, baseline waist-to-hip ratio as a covariate, and gender as a factor. | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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-to-hip 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 two-sided 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-to-hip ratio was analysed using a linear regression model, with end of treatment waist-to-hip ratio as the dependent variable, dose of GWP42003 as regressor, baseline waist-to-hip ratio as a covariate, and gender as a factor. | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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-to-hip 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 two-sided 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-to-hip ratio was analysed using a linear regression model, with end of treatment waist-to-hip ratio as the dependent variable, dose of GWP42003 as regressor, baseline waist-to-hip ratio as a covariate, and gender as a factor. | |

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | Subjects self-administered 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 |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
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 two-sided 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 non-inferiority margin, and other key parameters: |

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[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

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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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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[5] | Other relevant estimation information: |

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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

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
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 two-sided 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 non-inferiority margin, and other key parameters: |

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[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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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

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

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14. Secondary: | Change From Baseline to the End of Treatment in Mean Skin-fold 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 Skin-fold 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

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
7 | 6 | 7 | 5 |

Change From Baseline to the End of Treatment in Mean Skin-fold 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 Skin-fold 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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

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Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skin-fold 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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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[5] | Other relevant estimation information: |

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Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skin-fold 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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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[5] | Other relevant estimation information: |

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15. Secondary: | Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Midaxillary) [ Time Frame: After 56 days of treatment ] |

Measure Type | Secondary |
---|---|

Measure Title | Change From Baseline to the End of Treatment in Mean Skin-fold 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

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
7 | 6 | 7 | 5 |

Change From Baseline to the End of Treatment in Mean Skin-fold 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 Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

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Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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16. Secondary: | Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Triceps) [ Time Frame: After 56 days of treatment ] |

Measure Type | Secondary |
---|---|

Measure Title | Change From Baseline to the End of Treatment in Mean Skin-fold 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

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | Subjects self-administered 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 |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
7 | 6 | 7 | 5 |

Change From Baseline to the End of Treatment in Mean Skin-fold 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 Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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17. Secondary: | Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Subscapular) [ Time Frame: After 56 days of treatment ] |

Measure Type | Secondary |
---|---|

Measure Title | Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Subscapular) |

Measure Description | |

Time Frame | After 56 days of treatment |

Population Description

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
7 | 6 | 7 | 5 |

Change From Baseline to the End of Treatment in Mean Skin-fold 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 Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[5] | Other relevant estimation information: |

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Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[5] | Other relevant estimation information: |

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18. Secondary: | Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Abdomen) [ Time Frame: After 56 days of treatment ] |

Measure Type | Secondary |
---|---|

Measure Title | Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Abdomen) |

Measure Description | |

Time Frame | After 56 days of treatment |

Population Description

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
7 | 6 | 7 | 5 |

Change From Baseline to the End of Treatment in Mean Skin-fold 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 Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[5] | Other relevant estimation information: |

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Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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19. Secondary: | Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Suprailiac) [ Time Frame: After 56 days of treatment ] |

Measure Type | Secondary |
---|---|

Measure Title | Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Suprailiac) |

Measure Description | |

Time Frame | After 56 days of treatment |

Population Description

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
7 | 6 | 7 | 5 |

Change From Baseline to the End of Treatment in Mean Skin-fold 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 Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skin-fold 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: |
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[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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20. Secondary: | Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Thigh) [ Time Frame: After 56 days of treatment ] |

Measure Type | Secondary |
---|---|

Measure Title | Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Thigh) |

Measure Description | |

Time Frame | After 56 days of treatment |

Population Description

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | Subjects self-administered 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 |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
7 | 6 | 7 | 5 |

Change From Baseline to the End of Treatment in Mean Skin-fold 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 Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[5] | Other relevant estimation information: |

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21. Secondary: | Change From Baseline to the End of Treatment in Mean Total Skin-fold Thickness [ Time Frame: After 56 days of treatment ] |

Measure Type | Secondary |
---|---|

Measure Title | Change From Baseline to the End of Treatment in Mean Total Skin-fold 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

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
7 | 6 | 7 | 5 |

Change From Baseline to the End of Treatment in Mean Total Skin-fold 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 Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Total Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Total Skin-fold 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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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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

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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[5] | Other relevant estimation information: |

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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 two-sided 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 non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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[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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[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

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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: |
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[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[5] | Other relevant estimation information: |

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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: |
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[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[5] | Other relevant estimation information: |

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25. Secondary: | Change From Baseline to the End of Treatment in Mean Internal Non-abdominal Fat [ Time Frame: After 56 days of treatment ] |

Measure Type | Secondary |
---|---|

Measure Title | Change From Baseline to the End of Treatment in Mean Internal Non-abdominal Fat |

Measure Description | |

Time Frame | After 56 days of treatment |

Population Description

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
7 | 6 | 6 | 5 |

Change From Baseline to the End of Treatment in Mean Internal Non-abdominal 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 Non-abdominal Fat

Groups ^{[1]} |
200 mg GWP42003 vs. Placebo |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Regression, Linear |

P Value ^{[4]} |
0.700 |

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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Internal Non-abdominal Fat

Groups ^{[1]} |
400 mg GWP42003 vs. Placebo |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Regression, Linear |

P Value ^{[4]} |
0.958 |

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: |
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[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Internal Non-abdominal Fat

Groups ^{[1]} |
800 mg GWP42003 vs. Placebo |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Regression, Linear |

P Value ^{[4]} |
0.777 |

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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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26. Secondary: | Change From Baseline to the End of Treatment in Mean Subcutaneous Non-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 Non-abdominal Fat |

Measure Description | |

Time Frame | After 56 days of treatment |

Population Description

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
7 | 6 | 6 | 5 |

Change From Baseline to the End of Treatment in Mean Subcutaneous Non-abdominal 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 Non-abdominal Fat

Groups ^{[1]} |
200 mg GWP42003 vs. Placebo |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Regression, Linear |

P Value ^{[4]} |
0.409 |

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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Subcutaneous Non-abdominal Fat

Groups ^{[1]} |
400 mg GWP42003 vs. Placebo |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Regression, Linear |

P Value ^{[4]} |
0.485 |

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: |
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[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

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[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[5] | Other relevant estimation information: |

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Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Subcutaneous Non-abdominal Fat

Groups ^{[1]} |
800 mg GWP42003 vs. Placebo |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Regression, Linear |

P Value ^{[4]} |
0.429 |

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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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27. Secondary: | Change From Baseline to the End of Treatment in Mean Total Non-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 Non-abdominal Fat |

Measure Description | |

Time Frame | After 56 days of treatment |

Population Description

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
7 | 6 | 6 | 5 |

Change From Baseline to the End of Treatment in Mean Total Non-abdominal 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 Non-abdominal Fat

Groups ^{[1]} |
200 mg GWP42003 vs. Placebo |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Regression, Linear |

P Value ^{[4]} |
0.542 |

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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Total Non-abdominal Fat

Groups ^{[1]} |
400 mg GWP42003 vs. Placebo |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Regression, Linear |

P Value ^{[4]} |
0.584 |

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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Total Non-abdominal Fat

Groups ^{[1]} |
800 mg GWP42003 vs. Placebo |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Regression, Linear |

P Value ^{[4]} |
0.499 |

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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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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 | |

Time Frame | After 56 days of treatment |

Population Description

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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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: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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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 | -0.55 to 2.77 |

Standard Error of the mean | (0.956) |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

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[4] | |

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[5] | Other relevant estimation information: |

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29. Secondary: | Change From Baseline to the End of Treatment in Mean Total Subcutaneous Fat [ Time Frame: After 56 days of treatment ] |

Measure Type | Secondary |
---|---|

Measure Title | Change From Baseline to the End of Treatment in Mean Total Subcutaneous Fat |

Measure Description | |

Time Frame | After 56 days of treatment |

Population Description

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
7 | 6 | 6 | 5 |

Change From Baseline to the End of Treatment in Mean Total Subcutaneous Fat [Units: Litres] Mean (Standard Deviation) |
0.50 (0.54) | 0.19 (0.55) | 0.13 (0.93) | -0.66 (2.58) |

Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Total Subcutaneous Fat

Groups ^{[1]} |
200 mg GWP42003 vs. Placebo |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Regression, Linear |

P Value ^{[4]} |
0.245 |

Mean Difference (Final Values) ^{[5]} |
0.93 |

90% Confidence Interval | -0.41 to 2.27 |

Standard Error of the mean | (0.772) |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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 Subcutaneous Fat

Groups ^{[1]} |
400 mg GWP42003 vs. Placebo |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Regression, Linear |

P Value ^{[4]} |
0.479 |

Mean Difference (Final Values) ^{[5]} |
0.60 |

90% Confidence Interval | -0.84 to 2.04 |

Standard Error of the mean | (0.830) |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

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 Subcutaneous Fat

Groups ^{[1]} |
800 mg GWP42003 vs. Placebo |
---|---|

Statistical Test Type ^{[2]} |
Superiority or Other |

Statistical Method ^{[3]} |
Regression, Linear |

P Value ^{[4]} |
0.427 |

Mean Difference (Final Values) ^{[5]} |
0.70 |

90% Confidence Interval | -0.79 to 2.19 |

Standard Error of the mean | (0.860) |

[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
---|---|

[2] | Details of power calculation, definition of non-inferiority margin, and other key parameters: |

No text entered. | |

[3] | Other relevant method information, such as adjustments or degrees of freedom: |

No text entered. | |

[4] | |

No text entered. | |

[5] | Other relevant estimation information: |

No text entered. |

30. Secondary: | Change From Baseline to the End of Treatment in Mean Total Fat [ Time Frame: After 56 days of treatment ] |

Measure Type | Secondary |
---|---|

Measure Title | Change From Baseline to the End of Treatment in Mean Total Fat |

Measure Description | Total fat = total abdominal + total non-abdominal fat. A reduction from baseline (i.e. a negative value) indicates an improvement in condition. |

Time Frame | After 56 days of treatment |

Population Description

Reporting Groups

Description | |
---|---|

200 mg GWP42003 | |

400 mg GWP42003 | |

800 mg GWP42003 | |

Placebo |

Measured Values

200 mg GWP42003 | 400 mg GWP42003 | 800 mg GWP42003 | Placebo | |
---|---|---|---|---|

Participants Analyzed [Units: Participants] |
7 | 6 | 6 |