GWMD1092 - GWP42003 : GWP42004 Together Plus Alone in Type II Diabetes

• ClinicalTrials.gov Identifier: NCT01217112
• Recruitment Status: Completed
• First Posted: October 8, 2010
• Results First Posted: January 20, 2014
• Last Update Posted: September 18, 2014
• Sponsor: Jazz Pharmaceuticals
• Information provided by (Responsible Party): Jazz Pharmaceuticals

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: Dyslipidemias; Diabetes Mellitus, Type 2
• Interventions: Drug: GWP42003; Drug: GWP42004; Drug: Placebo
• Enrollment: 62

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Period Title: Overall Study
Started	11	12	13	12	14
Completed	11	10	12	10	13
Not Completed	0	2	1	2	1
Reason Not Completed
Adverse Event	0	2	0	2	0
Withdrawal by Subject	0	0	1	0	0
Physician Decision	0	0	0	0	1

Baseline Characteristics

Arm/Group Title		1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo	Total
Arm/Group Description		Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only	Total of all reporting groups
Overall Number of Baseline Participants		11	12	13	12	14	62
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	11 participants	12 participants	13 participants	12 participants	14 participants	62 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	8 72.7%	11 91.7%	11 84.6%	8 66.7%	10 71.4%	48 77.4%
	>=65 years	3 27.3%	1 8.3%	2 15.4%	4 33.3%	4 28.6%	14 22.6%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	11 participants	12 participants	13 participants	12 participants	14 participants	62 participants
		59.33 (8.75)	57.96 (8.11)	56.80 (9.92)	62.45 (12.58)	58.63 (7.72)	58.98 (9.41)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	11 participants	12 participants	13 participants	12 participants	14 participants	62 participants
	Female	5 45.5%	3 25.0%	3 23.1%	2 16.7%	7 50.0%	20 32.3%
	Male	6 54.5%	9 75.0%	10 76.9%	10 83.3%	7 50.0%	42 67.7%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United Kingdom	Number Analyzed	11 participants	12 participants	13 participants	12 participants	14 participants	62 participants
		11	12	13	12	14	62

Outcome Measures

1. Primary Outcome

Title	The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
Description	At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum High Density Lipoprotein cholesterol. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	13	12	13
Mean (Standard Deviation); Unit of Measure: mmol/l
	0.00 (0.09)	0.04 (0.07)	-0.04 (0.14)	0.00 (0.14)	0.02 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by analysis of covariance (ANCOVA). The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.766
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 90%; -0.09 to 0.06
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.044
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.424
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 90%; -0.04 to 0.11
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.043
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.412
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 90%; -0.10 to 0.04
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.041
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.668
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 90%; -0.05 to 0.09
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.043
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Description	At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of High Density Lipoprotein cholesterol by ultracentrifugation. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	9	12	14
Mean (Standard Deviation); Unit of Measure: mmol/l
	-0.04 (0.12)	-0.06 (0.08)	-0.11 (0.08)	-0.01 (0.16)	-0.02 (0.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.978
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 90%; -0.08 to 0.08
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.046
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.864
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 90%; -0.08 to 0.07
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.045
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.537
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 90%; -0.12 to 0.05
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.050
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.260
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 90%; -0.02 to 0.13
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.045
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	The Change From Baseline in Mean Serum Total Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
Description	At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	13	12	13
Mean (Standard Deviation); Unit of Measure: mmol/l
	-0.53 (0.78)	-0.27 (0.32)	-0.22 (0.50)	-0.13 (0.44)	-0.09 (0.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.088
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.31
	Confidence Interval	(2-Sided) 90%; -0.61 to -0.01
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.180
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.583
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.10
	Confidence Interval	(2-Sided) 90%; -0.20 to 0.39
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.177
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.388
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 90%; -0.14 to 0.43
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.169
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.580
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 90%; -0.19 to 0.38
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.170
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	The Change From Baseline in Mean Total Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Description	At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	9	12	14
Mean (Standard Deviation); Unit of Measure: mmol/l
	-0.12 (0.83)	-0.23 (0.28)	-0.11 (0.52)	-0.11 (0.45)	-0.16 (0.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.829
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 90%; -0.29 to 0.37
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.198
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.575
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 90%; -0.22 to 0.44
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.196
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.356
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.19
	Confidence Interval	(2-Sided) 90%; -0.15 to 0.53
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.203
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.472
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 90%; -0.18 to 0.45
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.188
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	The Change From Baseline in Mean Serum Low Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
Description	At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Low Density Lipoprotein cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	8	11	11	12	13
Mean (Standard Deviation); Unit of Measure: mmol/l
	-0.29 (0.62)	-0.13 (0.36)	-0.11 (0.40)	-0.02 (0.50)	0.07 (0.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.115
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 90%; -0.59 to 0.01
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.181
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.782
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 90%; -0.25 to 0.35
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.177
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.902
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 90%; -0.27 to 0.31
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.173
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.993
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 90%; -0.28 to 0.28
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.166
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	The Change From Baseline in Mean Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Description	At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	9	12	14
Mean (Standard Deviation); Unit of Measure: mmol/l
	-0.03 (0.49)	-0.16 (0.26)	-0.08 (0.43)	-0.08 (0.41)	-0.06 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.956
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 90%; -0.23 to 0.25
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.143
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.705
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 90%; -0.19 to 0.30
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.144
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.466
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 90%; -0.14 to 0.36
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.148
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.876
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 90%; -0.21 to 0.25
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.136
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	The Change From Baseline in Mean Serum High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio After 91 Days (13 Weeks) of Treatment
Description	An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	8	11	11	12	13
Mean (Standard Deviation); Unit of Measure: ratio
	0.03 (0.11)	0.04 (0.05)	-0.02 (0.08)	0.02 (0.09)	0.01 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.408
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 90%; -0.03 to 0.09
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.034
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.714
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 90%; -0.04 to 0.07
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.032
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.267
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.04
	Confidence Interval	(2-Sided) 90%; -0.09 to 0.02
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.032
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.484
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 90%; -0.03 to 0.08
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.032
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	The Change From Baseline in Mean High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Description	An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	9	12	14
Mean (Standard Deviation); Unit of Measure: ratio
	-0.01 (0.11)	0.00 (0.05)	-0.02 (0.08)	0.03 (0.12)	0.01 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.560
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 90%; -0.09 to 0.04
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.039
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.956
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 90%; -0.06 to 0.06
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.037
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.403
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 90%; -0.10 to 0.03
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.039
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.617
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 90%; -0.04 to 0.08
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.037
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	The Change From Baseline in Mean Very Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Description	At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Very Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	9	12	14
Mean (Standard Deviation); Unit of Measure: mmol/l
	-0.06 (0.37)	-0.01 (0.16)	0.08 (0.19)	-0.02 (0.24)	-0.08 (0.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.815
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 90%; -0.16 to 0.21
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.108
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.418
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 90%; -0.09 to 0.26
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.105
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.236
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.13
	Confidence Interval	(2-Sided) 90%; -0.05 to 0.32
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.111
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.556
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 90%; -0.11 to 0.23
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.103
	Estimation Comments	[Not Specified]

10. Secondary Outcome

Title	The Change From Baseline in Mean Serum Triglyceride Concentration After 91 Days (13 Weeks) of Treatment
Description	At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum triglyceride concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	13	12	13
Mean (Standard Deviation); Unit of Measure: mmol/l
	-0.47 (0.54)	0.14 (0.28)	0.09 (0.55)	0.09 (0.66)	-0.12 (0.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.329
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 90%; -0.64 to 0.17
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.241
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.232
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.28
	Confidence Interval	(2-Sided) 90%; -0.11 to 0.68
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.236
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.164
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.31
	Confidence Interval	(2-Sided) 90%; -0.06 to 0.68
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.222
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.302
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.24
	Confidence Interval	(2-Sided) 90%; -0.15 to 0.63
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.232
	Estimation Comments	[Not Specified]

11. Secondary Outcome

Title	The Change From Baseline in Mean Triglyceride Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Description	At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of triglyceride concentrations by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	9	12	14
Mean (Standard Deviation); Unit of Measure: mmol/l
	-0.16 (0.56)	0.12 (0.26)	0.16 (0.34)	0.05 (0.59)	-0.03 (0.74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.614
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.12
	Confidence Interval	(2-Sided) 90%; -0.50 to 0.27
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.231
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.669
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.10
	Confidence Interval	(2-Sided) 90%; -0.28 to 0.48
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.227
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.621
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 90%; -0.28 to 0.52
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.240
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.867
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 90%; -0.33 to 0.41
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.222
	Estimation Comments	[Not Specified]

12. Secondary Outcome

Title	The Change From Baseline in Mean Serum Apolipoprotein A Concentration After 91 Days (13 Weeks) of Treatment
Description	At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein A. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	13	12	14
Mean (Standard Deviation); Unit of Measure: umol/l
	-2.86 (8.84)	-3.51 (10.88)	-4.92 (6.04)	0.64 (11.32)	-3.41 (6.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.335
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.55
	Confidence Interval	(2-Sided) 90%; -1.84 to 6.95
	Parameter Dispersion	Type: Standard Error of the mean; Value: 2.624
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.358
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.36
	Confidence Interval	(2-Sided) 90%; -1.90 to 6.62
	Parameter Dispersion	Type: Standard Error of the mean; Value: 2.545
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.900
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.30
	Confidence Interval	(2-Sided) 90%; -3.72 to 4.33
	Parameter Dispersion	Type: Standard Error of the mean; Value: 2.406
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.019
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.02
	Confidence Interval	(2-Sided) 90%; 1.86 to 10.19
	Parameter Dispersion	Type: Standard Error of the mean; Value: 2.486
	Estimation Comments	[Not Specified]

13. Secondary Outcome

Title	The Change From Baseline in Mean Serum Apolipoprotein B Concentration After 91 Days (13 Weeks) of Treatment
Description	At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein B. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	13	12	13
Mean (Standard Deviation); Unit of Measure: umol/l
	-0.19 (0.84)	0.18 (0.51)	0.11 (0.53)	0.08 (0.66)	0.16 (0.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.325
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 90%; -0.65 to 0.17
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.245
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.438
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.19
	Confidence Interval	(2-Sided) 90%; -0.21 to 0.59
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.238
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.701
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 90%; -0.29 to 0.47
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.226
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.624
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 90%; -0.50 to 0.27
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.232
	Estimation Comments	[Not Specified]

14. Secondary Outcome

Title	The Change From Baseline in Mean Serum Apolipoprotein B : Apolipoprotein A Ratio After 91 Days (13 Weeks) of Treatment
Description	A decrease from baseline to the end of treatment (i.e. a negative value) in the Apolipoprotein B : Apolipoprotein A ratio indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	13	12	13
Mean (Standard Deviation); Unit of Measure: ratio
	-0.01 (0.23)	0.07 (0.15)	0.08 (0.13)	0.01 (0.14)	0.07 (0.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.233
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.07
	Confidence Interval	(2-Sided) 90%; -0.17 to 0.03
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.058
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.727
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 90%; -0.07 to 0.11
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.056
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.593
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 90%; -0.06 to 0.12
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.053
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.075
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 90%; -0.20 to -0.01
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.056
	Estimation Comments	[Not Specified]

15. Secondary Outcome

Title	The Change From Baseline in Mean Serum Non-Esterified Fatty Acid Concentration After 91 Days (13 Weeks) of Treatment
Description	At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Non-Esterified Fatty Acid concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	13	12	13
Mean (Standard Deviation); Unit of Measure: mmol/l
	0.06 (0.17)	-0.03 (0.23)	-0.05 (0.30)	-0.02 (0.18)	0.01 (0.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.236
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.10
	Confidence Interval	(2-Sided) 90%; -0.04 to 0.24
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.084
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.579
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 90%; -0.09 to 0.18
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.082
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.837
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 90%; -0.15 to 0.11
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.077
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.467
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 90%; -0.08 to 0.19
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.081
	Estimation Comments	[Not Specified]

16. Secondary Outcome

Title	The Change From Baseline in Mean Fasting Glucose Concentration After 91 Days (13 Weeks) of Treatment
Description	At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting glucose concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	13	11	13
Mean (Standard Deviation); Unit of Measure: mmol/l
	-0.23 (2.02)	0.44 (2.00)	0.41 (0.82)	-0.76 (1.00)	0.38 (1.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.533
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.38
	Confidence Interval	(2-Sided) 90%; -1.41 to 0.64
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.613
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.804
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 90%; -0.84 to 1.13
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.585
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.916
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 90%; -0.87 to 0.99
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.556
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.040
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.23
	Confidence Interval	(2-Sided) 90%; -2.20 to -0.25
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.583
	Estimation Comments	[Not Specified]

17. Secondary Outcome

Title	The Change From Baseline in Mean Fructosamine Concentration After 91 Days (13 Weeks) of Treatment
Description	At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fructosamine concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	10	13	12	13
Mean (Standard Deviation); Unit of Measure: umol/l
	2.8 (42.06)	14.5 (29.53)	-2.6 (20.41)	1.1 (11.68)	9.5 (19.68)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.366
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-9.90
	Confidence Interval	(2-Sided) 90%; -28.06 to 8.27
	Parameter Dispersion	Type: Standard Error of the mean; Value: 10.838
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.844
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.11
	Confidence Interval	(2-Sided) 90%; -15.81 to 20.03
	Parameter Dispersion	Type: Standard Error of the mean; Value: 10.692
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.118
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-15.96
	Confidence Interval	(2-Sided) 90%; -32.76 to 0.84
	Parameter Dispersion	Type: Standard Error of the mean; Value: 10.026
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.518
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.67
	Confidence Interval	(2-Sided) 90%; -23.86 to 10.51
	Parameter Dispersion	Type: Standard Error of the mean; Value: 10.256
	Estimation Comments	[Not Specified]

18. Secondary Outcome

Title	The Change From Baseline in Mean Glycated Haemoglobin Concentration After 91 Days (13 Weeks) of Treatment
Description	At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of glycated haemoglobin concentrations. At both time points, values were calculated as a percentage of total haemoglobin. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	13	12	14
Mean (Standard Deviation); Unit of Measure: percent
	0.14 (1.41)	0.16 (0.44)	0.08 (0.44)	-0.03 (0.22)	0.31 (0.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.576
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 90%; -0.66 to 0.33
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.294
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.648
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.13
	Confidence Interval	(2-Sided) 90%; -0.60 to 0.34
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.283
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.447
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.21
	Confidence Interval	(2-Sided) 90%; -0.66 to 0.24
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.269
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.273
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.31
	Confidence Interval	(2-Sided) 90%; -0.79 to 0.16
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.283
	Estimation Comments	[Not Specified]

19. Secondary Outcome

Title	The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Glucose Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test [OGTT])
Description	A two-hour OGTT was performed to investigate the rate of glucose metabolism or clearance from the blood with treatment. Blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum glucose levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. A reduction in the elevation of serum glucose levels at the end of treatment (i.e. a negative value) indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	6	10	12	11	13
Mean (Standard Deviation); Unit of Measure: mmol/l
	-0.07 (1.89)	1.09 (3.81)	-0.78 (1.51)	0.22 (1.85)	0.42 (1.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.615
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.56
	Confidence Interval	(2-Sided) 90%; -2.40 to 1.29
	Parameter Dispersion	Type: Standard Error of the mean; Value: 1.097
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.342
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 90%; -0.70 to 2.57
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.973
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.314
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.95
	Confidence Interval	(2-Sided) 90%; -2.52 to 0.62
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.934
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.889
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 90%; -1.48 to 1.75
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.964
	Estimation Comments	[Not Specified]

20. Secondary Outcome

Title	The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Insulin Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test)
Description	At baseline and the end of treatment, blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum insulin levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. An increase in the elevation of serum insulin levels from baseline to the end of treatment (i.e. a positive value) indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	7	9	12	11	13
Mean (Standard Deviation); Unit of Measure: pmol/l
	80.9 (223.91)	-156.6 (358.53)	-193.5 (232.17)	83.5 (427.94)	-40.8 (475.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.764
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	50.89
	Confidence Interval	(2-Sided) 90%; -232.02 to 333.80
	Parameter Dispersion	Type: Standard Error of the mean; Value: 168.459
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.654
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-70.76
	Confidence Interval	(2-Sided) 90%; -333.96 to 192.44
	Parameter Dispersion	Type: Standard Error of the mean; Value: 156.720
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.450
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-111.50
	Confidence Interval	(2-Sided) 90%; -357.17 to 134.16
	Parameter Dispersion	Type: Standard Error of the mean; Value: 146.276
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.517
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	97.42
	Confidence Interval	(2-Sided) 90%; -153.02 to 347.86
	Parameter Dispersion	Type: Standard Error of the mean; Value: 149.124
	Estimation Comments	[Not Specified]

21. Secondary Outcome

Title	The Change From Baseline in Mean Fasting Insulin Concentration After 91 Days (13 Weeks) of Treatment
Description	At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting insulin concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	13	11	13
Mean (Standard Deviation); Unit of Measure: pmol/l
	12.01 (56.22)	-6.06 (104.78)	13.44 (49.03)	45.62 (183.92)	2.79 (61.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.840
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.33
	Confidence Interval	(2-Sided) 90%; -60.28 to 76.94
	Parameter Dispersion	Type: Standard Error of the mean; Value: 40.940
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.834
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.31
	Confidence Interval	(2-Sided) 90%; -57.92 to 74.55
	Parameter Dispersion	Type: Standard Error of the mean; Value: 39.521
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.767
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-11.62
	Confidence Interval	(2-Sided) 90%; -77.06 to 53.81
	Parameter Dispersion	Type: Standard Error of the mean; Value: 39.044
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.289
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	42.51
	Confidence Interval	(2-Sided) 90%; -23.99 to 109.01
	Parameter Dispersion	Type: Standard Error of the mean; Value: 39.680
	Estimation Comments	[Not Specified]

22. Secondary Outcome

Title	The Change From Baseline in Mean C-peptide Concentration After 91 Days (13 Weeks) of Treatment
Description	At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of C-peptide concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	12	12	14
Mean (Standard Deviation); Unit of Measure: nmol/l
	0.02 (0.15)	0.09 (0.28)	-0.03 (0.18)	0.12 (0.31)	0.09 (0.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.569
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 90%; -0.24 to 0.12
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.106
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.984
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 90%; -0.17 to 0.17
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.101
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	v Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.176
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.13
	Confidence Interval	(2-Sided) 90%; -0.30 to 0.03
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.098
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.895
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 90%; -0.15 to 0.18
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.099
	Estimation Comments	[Not Specified]

23. Secondary Outcome

Title	The Change From Baseline in Mean Insulin Resistance Measured by Homeostasis Model Assessment 2 (HOMA2-IR) After 91 Days (13 Weeks) of Treatment
Description	Changes from baseline to the end of treatment in mean insulin resistance were calculated by HOMA2-IR. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance, which is the reciprocal of insulin sensitivity (%S)(100/%S) as a percentage of a normal reference population (normal young adults). A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	13	11	13
Mean (Standard Deviation); Unit of Measure: IR score
	0.19 (1.00)	-0.19 (2.54)	0.35 (1.20)	0.64 (3.15)	0.09 (1.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.871
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 90%; -1.13 to 1.37
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.745
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.826
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.16
	Confidence Interval	(2-Sided) 90%; -1.05 to 1.37
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.721
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GWP42003 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.693
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.28
	Confidence Interval	(2-Sided) 90%; -1.46 to 0.90
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.703
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GWP42004 and Placebo, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.536
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.45
	Confidence Interval	(2-Sided) 90%; -0.76 to 1.66
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.722
	Estimation Comments	[Not Specified]

24. Secondary Outcome

Title	The Change From Baseline in Mean Insulin Sensitivity Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment
Description	Changes from baseline to the end of treatment in mean insulin sensitivity were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time Frame	Baseline (Day 1) and End of treatment (Day 92)

Outcome Measure Data

Analysis Population Description

The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.

Arm/Group Title	1:1 GWP42003 : GWP42004	20:1 GWP42003 : GWP42004	GWP42003 and Placebo	GWP42004 and Placebo	Placebo
Arm/Group Description:	Contains 5 mg each of GWP42003 and GWP42004	Contains 100 mg GWP42003 and 5 mg GWP42004	Contains 100 mg GWP42003 and placebo (excipients only)	Contains GWP42004 5 mg and placebo (excipients only)	Contains excipients only
Overall Number of Participants Analyzed	9	11	13	11	13
Mean (Standard Deviation); Unit of Measure: percent sensitivity
	-5.26 (8.62)	-1.71 (12.62)	1.71 (26.48)	6.47 (27.00)	-4.07 (13.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	1:1 GWP42003 : GWP42004, Placebo
	Comments	Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.878
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.33
	Confidence Interval	(2-Sided) 90%; -15.80 to 13.13
	Parameter Dispersion	Type: Standard Error of the mean; Value: 8.633
	Estimation Comments	[Not Specified]

Statistical Analysis 2