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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020458-33 | EudraCT Number |
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This 15-19 week study is being conducted by GW Pharma Ltd as a pilot study in order to determine the efficacy and safety of two cannabinoids: GWP42004 and GWP42003 alone, or in combination in patients with Type 2 diabetes. This is the first study to determine whether the study medications have a positive benefit for subjects on their cholesterol levels, body weight, liver fat content and other metabolic parameters compared with a placebo medication.
In this study there was a 1-5 week baseline period followed by a 13 week treatment period, and a one week follow-up. Eligible subjects entered the study at a screening visit (Visit 1) before returning for randomisation (Visit 2, Day 1). At the discretion of the investigator (based on individual subjects), Visit 1 could be split into two separate visits (Visits 1A and B) to allow a 21-day washout period of prohibited medications prior to blood sampling for eligibility. Further outpatient study visits (for assessment purposes) took place at the study site at the end of Week 4 of treatment (Visit 3, Day 29), and at the overall end of treatment at Week 13 (Visit 5, Day 92). A telephone assessment was also performed at Day 57 (Visit 4) and at Week 14 (Visit 6, Day 99) for safety follow-up purposes.
During the 13 week randomised treatment phase, subjects received blinded, oral doses of their allocated randomised treatment twice daily. Treatment was self-administered on an outpatient basis, once in the morning and once in the evening for 13 weeks. Subjects were instructed to time study medication to 30 minutes before breakfast and evening meals.
Physical and metabolic parameters were assessed before, during and after treatment to evaluate clinical response. Diabetic and dyslipidaemic medication usage (where applicable), and appetite 0-10 NRS data were collected daily during the treatment period, using the study diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GWP42004 and placebo | Active Comparator | Contains GWP42004 5 mg and placebo (excipients only) |
|
| 1:1 GWP42003 : GWP42004 | Active Comparator | Contains 5 mg each of GWP42003 and GWP42004 |
|
| 20:1 GWP42003 : GWP42004 | Active Comparator | Contains 100 mg GWP42003 and 5 mg GWP42004 |
|
| Placebo | Placebo Comparator | Contains excipients only |
|
| GWP42003 and placebo | Active Comparator | Contains 100 mg GWP42003 and placebo (excipients only) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GWP42003 | Drug | 100 mg capsules, PO, BD, 91 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Subject is taking insulin (i.e. they are insulin-dependent);
Taking the following categories of medicines: fibrates, Thiazolidinediones, therapeutic Omega-3 fatty acids, alpha-glucosidase inhibitors and unwilling abstain for the duration of the study;
Currently using or has used recreational cannabis, medicinal cannabis, cannabinoid medications (including Sativex®), or synthetic cannabinoid based medications within 30 days prior to study entry and unwilling to abstain for the duration for the study;
Any known or suspected history of:
Any known or suspected history of depression sufficient to require treatment with antidepressants or disrupt ordinary life at the discretion of the investigator);
Subject who has significant history of anxiety, suicidal ideation or self-harm;
Clinically significant cardiac, renal or hepatic impairment in the opinion of the investigator;
Genetic dyslipidaemic condition in the opinion of the investigator;
Currently taking a lipid lowering agent and a stable dose has not been maintained for at least four weeks randomisation (Visit 2);
Female subject, who is pregnant, lactating or planning pregnancy during the course of the study and for three months from date of last dose;
Female subjects of child bearing potential unless willing to use two forms of contraception, one of which must be barrier contraception (e.g. female condom or occlusive cap (diaphragm or cervical vault/caps) with spermicide) during the study and for three months thereafter;
Male subjects whose partner is of child bearing potential, unless willing to use an appropriate barrier method of contraception (condom and spermicide) in addition to having their female partner use another form of barrier contraception (e.g. female condom or occlusive cap (diaphragm or cervical vault/caps) with spermicide) during the study and for three months thereafter;
Body weight > 150kg;
Travel outside the country of residence planned during the study;
Currently receiving a prohibited medication and unwilling to stop at the screening visit and for the duration of the study;
Received an unapproved Investigational Medicinal Product (IMP) within the 30 days before the screening visit;
In the opinion of the investigator, is not considered to be suitable for the study;
Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP(s);
Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, may influence the result of the study, or the subject's ability to participate in the study;
Has a postural drop of ≥ 20 mmHg in systolic blood pressure at Visit 1;
Any abnormalities identified during the physical exam at Visit 1 that in the opinion of the investigator, would prevent the subject from safe participation in the study;
Unwilling to abstain from donation of blood during the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woolpit Health Centre | Bury Saint Edmonds | IP30 9QU | United Kingdom | |||
| Mount Farm Surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27573936 | Derived | Jadoon KA, Ratcliffe SH, Barrett DA, Thomas EL, Stott C, Bell JD, O'Sullivan SE, Tan GD. Efficacy and Safety of Cannabidiol and Tetrahydrocannabivarin on Glycemic and Lipid Parameters in Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Pilot Study. Diabetes Care. 2016 Oct;39(10):1777-86. doi: 10.2337/dc16-0650. Epub 2016 Aug 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1:1 GWP42003 : GWP42004 | Contains 5 mg each of GWP42003 and GWP42004 |
| FG001 | 20:1 GWP42003 : GWP42004 | Contains 100 mg GWP42003 and 5 mg GWP42004 |
| FG002 | GWP42003 and Placebo | Contains 100 mg GWP42003 and placebo (excipients only) |
| FG003 | GWP42004 and Placebo | Contains GWP42004 5 mg and placebo (excipients only) |
| FG004 | Placebo | Contains excipients only |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1:1 GWP42003 : GWP42004 | Contains 5 mg each of GWP42003 and GWP42004 |
| BG001 | 20:1 GWP42003 : GWP42004 | Contains 100 mg GWP42003 and 5 mg GWP42004 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | mmol/l | Baseline (Day 1) and End of treatment (Day 92) |
|
All adverse events occurring during the study (up to 133 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1:1 GWP42003 : GWP42004 | Contains 5 mg each of GWP42003 and GWP42004 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial ischaemia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Richard Potts, Clinical Operations Director | GW Research Ltd. | 0044 1223266800 | rp@gwpharm.com |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| GWP42003 | Drug | 5 mg capsules, PO, BD, 91 days |
|
|
| GWP42004 | Drug | 5 mg capsules, PO, BD, 91 days |
|
|
| Placebo | Drug | 0 mg capsules, QDS, PO, 91 days |
|
| Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Serum Total Cholesterol Concentration After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Total Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Serum Low Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Serum High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Very Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Serum Triglyceride Concentration After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Triglyceride Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Serum Apolipoprotein A Concentration After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Serum Apolipoprotein B Concentration After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Serum Apolipoprotein B : Apolipoprotein A Ratio After 91 Days (13 Weeks) of Treatment | A decrease from baseline to the end of treatment (i.e. a negative value) in the Apolipoprotein B : Apolipoprotein A ratio indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Serum Non-Esterified Fatty Acid Concentration After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Fasting Glucose Concentration After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Fructosamine Concentration After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Glycated Haemoglobin Concentration After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| 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]) | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| 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) | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Fasting Insulin Concentration After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean C-peptide Concentration After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Insulin Resistance Measured by Homeostasis Model Assessment 2 (HOMA2-IR) After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Insulin Sensitivity Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment | 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Insulin B Cell Function Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment | Changes from baseline to the end of treatment in mean insulin B Cell Function were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate beta cell function (%B) 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. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Body Mass Index After 91 Days (13 Weeks) of Treatment | Body Mass Index was calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Waist-to-hip Ratio After 91 Days (13 Weeks) of Treatment | Subject's waist-to-hip ratios were calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Body Weight After 91 Days (13 Weeks) of Treatment | Subject's body weights were measured at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Waist Measurement After 91 Days (13 Weeks) of Treatment | Subjects' waist measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Hip Measurement After 91 Days (13 Weeks) of Treatment | Subjects' hip measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Visceral Abdominal Fat After 91 Days (13 Weeks) of Treatment | Visceral Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Subcutaneous Abdominal Fat After 91 Days (13 Weeks) of Treatment | Subcutaneous Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Total Abdominal Fat After 91 Days (13 Weeks) of Treatment | Total Abdominal Fat was measured by magnetic resonance imaging, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Internal Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment | Internal Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Subcutaneous Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment | Subcutaneous Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Total Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment | Total Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Total Internal Fat After 91 Days (13 Weeks) of Treatment | Total Internal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Total Subcutaneous Fat After 91 Days (13 Weeks) of Treatment | Total Subcutaneous Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Total Fat After 91 Days (13 Weeks) of Treatment | Total Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Abdominal Adiposity After 91 Days (13 Weeks) of Treatment | Abdominal Adiposity was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean % Liver Fat After 91 Days (13 Weeks) of Treatment | Percentage liver fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| The Change From Baseline in Mean Appetite 0-10 Numerical Rating Scale Score After 91 Days (13 Weeks) of Treatment | Subjects scored their appetite daily using an appetite 0-10 numerical rating scale score where 0 = no appetite (don't feel hungry) and 10 = maximum appetite (completely hungry all the time). The mean change from baseline to the end of treatment in scores were calculated. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | Baseline (Day 1) and End of treatment (Day 92) |
| Adverse Events as a Measure of Patient Safety | The incidence of treatment-emergent adverse events was recorded for the study duration, and the number of patients who experienced an adverse event is presented. | Day 1 - Day 92 |
| The Change From Baseline in Mean Beck Depression Inventory-II (BDI-II) Score at the End of 91 Days (13 Weeks) of Treatment | The BDI-II is a 21 question, multiple choice, self-reported inventory, and is one of the most widely used instruments for measuring the severity of depression. The 21 questions or items each had four possible responses. Each response was assigned a score ranging from zero to three, indicating the severity of the symptom, with a total possible score ranging from zero to 63. A score between zero and 13 indicates 'minimal depression'. A score between 14 and 19 indicates 'mild depression'. A score between 20 and 28 indicates 'moderate depression', and a score between 29 and 63 indicates 'severe depression'. As such, an increase from baseline to the end of treatment, a positive value, indicates a deterioration. | Baseline (Day 1) and the End of Treatment (Day 92) |
| Bury Saint Edmonds |
| IP32 7EW |
| United Kingdom |
| University of Nottingham, Medical School at Derby, Royal Derby Hospital | Derby | DE22 3DT | United Kingdom |
| James Paget University Hospital | Gorleston-on-Sea, Norfolk | NR31 6LA | United Kingdom |
| MAC UK Neuroscience Ltd. | Manchester | M32 0UT | United Kingdom |
| Withdrawal by Subject |
|
| Physician Decision |
|
| BG002 | GWP42003 and Placebo | Contains 100 mg GWP42003 and placebo (excipients only) |
| BG003 | GWP42004 and Placebo | Contains GWP42004 5 mg and placebo (excipients only) |
| BG004 | Placebo | Contains excipients only |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Contains 100 mg GWP42003 and 5 mg GWP42004 |
| OG002 | GWP42003 and Placebo | Contains 100 mg GWP42003 and placebo (excipients only) |
| OG003 | GWP42004 and Placebo | Contains GWP42004 5 mg and placebo (excipients only) |
| OG004 | Placebo | Contains excipients only |
|
|
|
| Secondary | The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | mmol/l | Baseline (Day 1) and End of treatment (Day 92) |
|
|
|
|
| Secondary | The Change From Baseline in Mean Serum Total Cholesterol Concentration After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | mmol/l | Baseline (Day 1) and End of treatment (Day 92) |
|
|
|
|
| Secondary | The Change From Baseline in Mean Total Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | mmol/l | Baseline (Day 1) and End of treatment (Day 92) |
|
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|
|
| Secondary | The Change From Baseline in Mean Serum Low Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | mmol/l | Baseline (Day 1) and End of treatment (Day 92) |
|
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| Secondary | The Change From Baseline in Mean Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | mmol/l | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Serum High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | ratio | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | ratio | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Very Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | mmol/l | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Serum Triglyceride Concentration After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | mmol/l | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Triglyceride Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | mmol/l | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Serum Apolipoprotein A Concentration After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | umol/l | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Serum Apolipoprotein B Concentration After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | umol/l | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Serum Apolipoprotein B : Apolipoprotein A Ratio After 91 Days (13 Weeks) of Treatment | A decrease from baseline to the end of treatment (i.e. a negative value) in the Apolipoprotein B : Apolipoprotein A ratio indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | ratio | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Serum Non-Esterified Fatty Acid Concentration After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | mmol/l | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Fasting Glucose Concentration After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | mmol/l | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Fructosamine Concentration After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | umol/l | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Glycated Haemoglobin Concentration After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | percent | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | 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]) | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | mmol/l | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | 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) | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | pmol/l | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Fasting Insulin Concentration After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | pmol/l | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean C-peptide Concentration After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | nmol/l | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Insulin Resistance Measured by Homeostasis Model Assessment 2 (HOMA2-IR) After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | IR score | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Insulin Sensitivity Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment | 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | percent sensitivity | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Insulin B Cell Function Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment | Changes from baseline to the end of treatment in mean insulin B Cell Function were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate beta cell function (%B) 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. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | percent beta function | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Body Mass Index After 91 Days (13 Weeks) of Treatment | Body Mass Index was calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Waist-to-hip Ratio After 91 Days (13 Weeks) of Treatment | Subject's waist-to-hip ratios were calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | ratio | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Body Weight After 91 Days (13 Weeks) of Treatment | Subject's body weights were measured at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | kg | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Waist Measurement After 91 Days (13 Weeks) of Treatment | Subjects' waist measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | cm | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Hip Measurement After 91 Days (13 Weeks) of Treatment | Subjects' hip measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | cm | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Visceral Abdominal Fat After 91 Days (13 Weeks) of Treatment | Visceral Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | litres | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Subcutaneous Abdominal Fat After 91 Days (13 Weeks) of Treatment | Subcutaneous Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | litres | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Total Abdominal Fat After 91 Days (13 Weeks) of Treatment | Total Abdominal Fat was measured by magnetic resonance imaging, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | litres | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Internal Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment | Internal Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | litres | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Subcutaneous Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment | Subcutaneous Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | litres | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Total Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment | Total Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | litres | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Total Internal Fat After 91 Days (13 Weeks) of Treatment | Total Internal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | litres | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Total Subcutaneous Fat After 91 Days (13 Weeks) of Treatment | Total Subcutaneous Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | litres | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Total Fat After 91 Days (13 Weeks) of Treatment | Total Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | litres | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Abdominal Adiposity After 91 Days (13 Weeks) of Treatment | Abdominal Adiposity was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | litres | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean % Liver Fat After 91 Days (13 Weeks) of Treatment | Percentage liver fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | percent liver fat | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | The Change From Baseline in Mean Appetite 0-10 Numerical Rating Scale Score After 91 Days (13 Weeks) of Treatment | Subjects scored their appetite daily using an appetite 0-10 numerical rating scale score where 0 = no appetite (don't feel hungry) and 10 = maximum appetite (completely hungry all the time). The mean change from baseline to the end of treatment in scores were calculated. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1) and End of treatment (Day 92) |
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| Secondary | Adverse Events as a Measure of Patient Safety | The incidence of treatment-emergent adverse events was recorded for the study duration, and the number of patients who experienced an adverse event is presented. | All correctly randomised subjects who received at least one dose of study treatment were included and analysed according to the treatment received. | Posted | Number | participants | Day 1 - Day 92 |
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| Secondary | The Change From Baseline in Mean Beck Depression Inventory-II (BDI-II) Score at the End of 91 Days (13 Weeks) of Treatment | The BDI-II is a 21 question, multiple choice, self-reported inventory, and is one of the most widely used instruments for measuring the severity of depression. The 21 questions or items each had four possible responses. Each response was assigned a score ranging from zero to three, indicating the severity of the symptom, with a total possible score ranging from zero to 63. A score between zero and 13 indicates 'minimal depression'. A score between 14 and 19 indicates 'mild depression'. A score between 20 and 28 indicates 'moderate depression', and a score between 29 and 63 indicates 'severe depression'. As such, an increase from baseline to the end of treatment, a positive value, indicates a deterioration. | The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1) and the End of Treatment (Day 92) |
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| 1 |
| 11 |
| 7 |
| 11 |
| EG001 | 20:1 GWP42003 : GWP42004 | Contains 100 mg GWP42003 and 5 mg GWP42004 | 2 | 12 | 8 | 12 |
| EG002 | GWP42003 and Placebo | Contains 100 mg GWP42003 and placebo (excipients only) | 0 | 13 | 11 | 13 |
| EG003 | GWP42004 and Placebo | Contains GWP42004 5 mg and placebo (excipients only) | 0 | 12 | 11 | 12 |
| EG004 | Placebo | Contains excipients only | 1 | 14 | 13 | 14 |
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Self-injurious ideation | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment | This event was added post study completion at the Sponsors request after review of the Beck Depression Inventory-II questionnaire responses. |
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| Suicidal ideation | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment | This event was added post study completion at the Sponsors request after review of the Beck Depression Inventory-II questionnaire responses. |
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| Myocardial ischaemia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Dermoid cyst | Congenital, familial and genetic disorders | MedDRA 13.1 | Systematic Assessment |
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| Hyperparathyroidism primary | Endocrine disorders | MedDRA 13.1 | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Retinal haemorrhage | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Change of bowel habit | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Vessel puncture site reaction | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Hepatic steatosis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
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| Ear infection fungal | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Genital candidiasis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Tinea pedis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Foreign body | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Joint sprain | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
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| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
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| Cardiac murmur | Investigations | MedDRA 13.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 13.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Carpal tunnel syndrome | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| Affect lability | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Hypertonic bladder | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Skin odour abnormal | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
GW Pharmaceuticals Ltd (GW) will coordinate the dissemination of data from this study and may solicit input and assistance from the principal investigator. All publications, for example manuscripts, abstracts, oral/slide presentations or book chapters based on this study, must be submitted to GW for corporate review before release.
| D004700 | Endocrine System Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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. |
| ANCOVA |
| 0.864 |
| Mean Difference (Final Values) |
| -0.01 |
| Standard Error of the Mean |
| 0.045 |
| 2-Sided |
| 90 |
| -0.08 |
| 0.07 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.537 | Mean Difference (Final Values) | -0.03 | Standard Error of the Mean | 0.050 | 2-Sided | 90 | -0.12 | 0.05 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.260 | Mean Difference (Final Values) | 0.05 | Standard Error of the Mean | 0.045 | 2-Sided | 90 | -0.02 | 0.13 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.583 |
| Mean Difference (Final Values) |
| 0.10 |
| Standard Error of the Mean |
| 0.177 |
| 2-Sided |
| 90 |
| -0.20 |
| 0.39 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.388 | Mean Difference (Final Values) | 0.15 | Standard Error of the Mean | 0.169 | 2-Sided | 90 | -0.14 | 0.43 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.580 | Mean Difference (Final Values) | 0.09 | Standard Error of the Mean | 0.170 | 2-Sided | 90 | -0.19 | 0.38 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.575 |
| Mean Difference (Final Values) |
| 0.11 |
| Standard Error of the Mean |
| 0.196 |
| 2-Sided |
| 90 |
| -0.22 |
| 0.44 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.356 | Mean Difference (Final Values) | 0.19 | Standard Error of the Mean | 0.203 | 2-Sided | 90 | -0.15 | 0.53 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.472 | Mean Difference (Final Values) | 0.14 | Standard Error of the Mean | 0.188 | 2-Sided | 90 | -0.18 | 0.45 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.782 |
| Mean Difference (Final Values) |
| 0.05 |
| Standard Error of the Mean |
| 0.177 |
| 2-Sided |
| 90 |
| -0.25 |
| 0.35 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.902 | Mean Difference (Final Values) | 0.02 | Standard Error of the Mean | 0.173 | 2-Sided | 90 | -0.27 | 0.31 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.993 | Mean Difference (Final Values) | 0.00 | Standard Error of the Mean | 0.166 | 2-Sided | 90 | -0.28 | 0.28 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.705 |
| Mean Difference (Final Values) |
| 0.05 |
| Standard Error of the Mean |
| 0.144 |
| 2-Sided |
| 90 |
| -0.19 |
| 0.30 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.466 | Mean Difference (Final Values) | 0.11 | Standard Error of the Mean | 0.148 | 2-Sided | 90 | -0.14 | 0.36 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.876 | Mean Difference (Final Values) | 0.02 | Standard Error of the Mean | 0.136 | 2-Sided | 90 | -0.21 | 0.25 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.714 |
| Mean Difference (Final Values) |
| 0.01 |
| Standard Error of the Mean |
| 0.032 |
| 2-Sided |
| 90 |
| -0.04 |
| 0.07 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.267 | Mean Difference (Final Values) | -0.04 | Standard Error of the Mean | 0.032 | 2-Sided | 90 | -0.09 | 0.02 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.484 | Mean Difference (Final Values) | 0.02 | Standard Error of the Mean | 0.032 | 2-Sided | 90 | -0.03 | 0.08 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.956 |
| Mean Difference (Final Values) |
| 0.00 |
| Standard Error of the Mean |
| 0.037 |
| 2-Sided |
| 90 |
| -0.06 |
| 0.06 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.403 | Mean Difference (Final Values) | -0.03 | Standard Error of the Mean | 0.039 | 2-Sided | 90 | -0.10 | 0.03 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.617 | Mean Difference (Final Values) | 0.02 | Standard Error of the Mean | 0.037 | 2-Sided | 90 | -0.04 | 0.08 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.418 |
| Mean Difference (Final Values) |
| 0.09 |
| Standard Error of the Mean |
| 0.105 |
| 2-Sided |
| 90 |
| -0.09 |
| 0.26 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.236 | Mean Difference (Final Values) | 0.13 | Standard Error of the Mean | 0.111 | 2-Sided | 90 | -0.05 | 0.32 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.556 | Mean Difference (Final Values) | 0.06 | Standard Error of the Mean | 0.103 | 2-Sided | 90 | -0.11 | 0.23 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.232 |
| Mean Difference (Final Values) |
| 0.28 |
| Standard Error of the Mean |
| 0.236 |
| 2-Sided |
| 90 |
| -0.11 |
| 0.68 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.164 | Mean Difference (Final Values) | 0.31 | Standard Error of the Mean | 0.222 | 2-Sided | 90 | -0.06 | 0.68 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.302 | Mean Difference (Final Values) | 0.24 | Standard Error of the Mean | 0.232 | 2-Sided | 90 | -0.15 | 0.63 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.669 |
| Mean Difference (Final Values) |
| 0.10 |
| Standard Error of the Mean |
| 0.227 |
| 2-Sided |
| 90 |
| -0.28 |
| 0.48 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.621 | Mean Difference (Final Values) | 0.12 | Standard Error of the Mean | 0.240 | 2-Sided | 90 | -0.28 | 0.52 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.867 | Mean Difference (Final Values) | 0.04 | Standard Error of the Mean | 0.222 | 2-Sided | 90 | -0.33 | 0.41 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.358 |
| Mean Difference (Final Values) |
| 2.36 |
| Standard Error of the Mean |
| 2.545 |
| 2-Sided |
| 90 |
| -1.90 |
| 6.62 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.900 | Mean Difference (Final Values) | 0.30 | Standard Error of the Mean | 2.406 | 2-Sided | 90 | -3.72 | 4.33 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.019 | Mean Difference (Final Values) | 6.02 | Standard Error of the Mean | 2.486 | 2-Sided | 90 | 1.86 | 10.19 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.438 |
| Mean Difference (Final Values) |
| 0.19 |
| Standard Error of the Mean |
| 0.238 |
| 2-Sided |
| 90 |
| -0.21 |
| 0.59 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.701 | Mean Difference (Final Values) | 0.09 | Standard Error of the Mean | 0.226 | 2-Sided | 90 | -0.29 | 0.47 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.624 | Mean Difference (Final Values) | -0.11 | Standard Error of the Mean | 0.232 | 2-Sided | 90 | -0.50 | 0.27 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.727 |
| Mean Difference (Final Values) |
| 0.02 |
| Standard Error of the Mean |
| 0.056 |
| 2-Sided |
| 90 |
| -0.07 |
| 0.11 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.593 | Mean Difference (Final Values) | 0.03 | Standard Error of the Mean | 0.053 | 2-Sided | 90 | -0.06 | 0.12 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.075 | Mean Difference (Final Values) | -0.10 | Standard Error of the Mean | 0.056 | 2-Sided | 90 | -0.20 | -0.01 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.579 |
| Mean Difference (Final Values) |
| 0.05 |
| Standard Error of the Mean |
| 0.082 |
| 2-Sided |
| 90 |
| -0.09 |
| 0.18 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.837 | Mean Difference (Final Values) | -0.02 | Standard Error of the Mean | 0.077 | 2-Sided | 90 | -0.15 | 0.11 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.467 | Mean Difference (Final Values) | 0.06 | Standard Error of the Mean | 0.081 | 2-Sided | 90 | -0.08 | 0.19 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.804 |
| Mean Difference (Final Values) |
| 0.15 |
| Standard Error of the Mean |
| 0.585 |
| 2-Sided |
| 90 |
| -0.84 |
| 1.13 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.916 | Mean Difference (Final Values) | 0.06 | Standard Error of the Mean | 0.556 | 2-Sided | 90 | -0.87 | 0.99 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.040 | Mean Difference (Final Values) | -1.23 | Standard Error of the Mean | 0.583 | 2-Sided | 90 | -2.20 | -0.25 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.844 |
| Mean Difference (Final Values) |
| 2.11 |
| Standard Error of the Mean |
| 10.692 |
| 2-Sided |
| 90 |
| -15.81 |
| 20.03 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.118 | Mean Difference (Final Values) | -15.96 | Standard Error of the Mean | 10.026 | 2-Sided | 90 | -32.76 | 0.84 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.518 | Mean Difference (Final Values) | -6.67 | Standard Error of the Mean | 10.256 | 2-Sided | 90 | -23.86 | 10.51 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.648 |
| Mean Difference (Final Values) |
| -0.13 |
| Standard Error of the Mean |
| 0.283 |
| 2-Sided |
| 90 |
| -0.60 |
| 0.34 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.447 | Mean Difference (Final Values) | -0.21 | Standard Error of the Mean | 0.269 | 2-Sided | 90 | -0.66 | 0.24 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.273 | Mean Difference (Final Values) | -0.31 | Standard Error of the Mean | 0.283 | 2-Sided | 90 | -0.79 | 0.16 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.342 |
| Mean Difference (Final Values) |
| 0.93 |
| Standard Error of the Mean |
| 0.973 |
| 2-Sided |
| 90 |
| -0.70 |
| 2.57 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.314 | Mean Difference (Final Values) | -0.95 | Standard Error of the Mean | 0.934 | 2-Sided | 90 | -2.52 | 0.62 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.889 | Mean Difference (Final Values) | 0.14 | Standard Error of the Mean | 0.964 | 2-Sided | 90 | -1.48 | 1.75 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.654 |
| Mean Difference (Final Values) |
| -70.76 |
| Standard Error of the Mean |
| 156.720 |
| 2-Sided |
| 90 |
| -333.96 |
| 192.44 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.450 | Mean Difference (Final Values) | -111.50 | Standard Error of the Mean | 146.276 | 2-Sided | 90 | -357.17 | 134.16 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.517 | Mean Difference (Final Values) | 97.42 | Standard Error of the Mean | 149.124 | 2-Sided | 90 | -153.02 | 347.86 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.834 |
| Mean Difference (Final Values) |
| 8.31 |
| Standard Error of the Mean |
| 39.521 |
| 2-Sided |
| 90 |
| -57.92 |
| 74.55 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.767 | Mean Difference (Final Values) | -11.62 | Standard Error of the Mean | 39.044 | 2-Sided | 90 | -77.06 | 53.81 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.289 | Mean Difference (Final Values) | 42.51 | Standard Error of the Mean | 39.680 | 2-Sided | 90 | -23.99 | 109.01 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.984 |
| Mean Difference (Final Values) |
| 0.00 |
| Standard Error of the Mean |
| 0.101 |
| 2-Sided |
| 90 |
| -0.17 |
| 0.17 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.176 | Mean Difference (Final Values) | -0.13 | Standard Error of the Mean | 0.098 | 2-Sided | 90 | -0.30 | 0.03 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.895 | Mean Difference (Final Values) | 0.01 | Standard Error of the Mean | 0.099 | 2-Sided | 90 | -0.15 | 0.18 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.826 |
| Mean Difference (Final Values) |
| 0.16 |
| Standard Error of the Mean |
| 0.721 |
| 2-Sided |
| 90 |
| -1.05 |
| 1.37 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.693 | Mean Difference (Final Values) | -0.28 | Standard Error of the Mean | 0.703 | 2-Sided | 90 | -1.46 | 0.90 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.536 | Mean Difference (Final Values) | 0.45 | Standard Error of the Mean | 0.722 | 2-Sided | 90 | -0.76 | 1.66 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.919 |
| Mean Difference (Final Values) |
| 0.85 |
| Standard Error of the Mean |
| 8.377 |
| 2-Sided |
| 90 |
| -13.18 |
| 14.89 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.557 | Mean Difference (Final Values) | 4.72 | Standard Error of the Mean | 7.989 | 2-Sided | 90 | -8.67 | 18.11 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.275 | Mean Difference (Final Values) | 9.20 | Standard Error of the Mean | 8.328 | 2-Sided | 90 | -4.76 | 23.16 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.990 |
| Mean Difference (Final Values) |
| 0.20 |
| Standard Error of the Mean |
| 15.825 |
| 2-Sided |
| 90 |
| -26.32 |
| 26.72 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.776 | Mean Difference (Final Values) | 4.39 | Standard Error of the Mean | 15.369 | 2-Sided | 90 | -21.37 | 30.15 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.007 | Mean Difference (Final Values) | 44.51 | Standard Error of the Mean | 15.834 | 2-Sided | 90 | 17.98 | 71.05 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.218 |
| Mean Difference (Final Values) |
| 0.66 |
| Standard Error of the Mean |
| 0.531 |
| 2-Sided |
| 90 |
| -0.23 |
| 1.55 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.378 | Mean Difference (Final Values) | 0.46 | Standard Error of the Mean | 0.514 | 2-Sided | 90 | -0.40 | 1.32 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.361 | Mean Difference (Final Values) | 0.49 | Standard Error of the Mean | 0.532 | 2-Sided | 90 | -0.40 | 1.38 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.340 |
| Mean Difference (Final Values) |
| 0.01 |
| Standard Error of the Mean |
| 0.013 |
| 2-Sided |
| 90 |
| -0.01 |
| 0.04 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.915 | Mean Difference (Final Values) | -0.00 | Standard Error of the Mean | 0.013 | 2-Sided | 90 | -0.02 | 0.02 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.465 | Mean Difference (Final Values) | 0.01 | Standard Error of the Mean | 0.013 | 2-Sided | 90 | -0.01 | 0.03 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.219 |
| Mean Difference (Final Values) |
| 1.99 |
| Standard Error of the Mean |
| 1.598 |
| 2-Sided |
| 90 |
| -0.69 |
| 4.66 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.307 | Mean Difference (Final Values) | 1.61 | Standard Error of the Mean | 1.563 | 2-Sided | 90 | -1.00 | 4.23 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.348 | Mean Difference (Final Values) | 1.52 | Standard Error of the Mean | 1.612 | 2-Sided | 90 | -1.17 | 4.22 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.578 |
| Mean Difference (Final Values) |
| 0.72 |
| Standard Error of the Mean |
| 1.280 |
| 2-Sided |
| 90 |
| -1.43 |
| 2.86 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.368 | Mean Difference (Final Values) | 1.13 | Standard Error of the Mean | 1.249 | 2-Sided | 90 | -0.96 | 3.22 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.696 | Mean Difference (Final Values) | 0.51 | Standard Error of the Mean | 1.304 | 2-Sided | 90 | -1.67 | 2.69 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.851 |
| Mean Difference (Final Values) |
| 0.25 |
| Standard Error of the Mean |
| 1.303 |
| 2-Sided |
| 90 |
| -1.93 |
| 2.43 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.672 | Mean Difference (Final Values) | 0.54 | Standard Error of the Mean | 1.281 | 2-Sided | 90 | -1.60 | 2.69 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.978 | Mean Difference (Final Values) | -0.04 | Standard Error of the Mean | 1.327 | 2-Sided | 90 | -2.26 | 2.18 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.543 |
| Mean Difference (Final Values) |
| 0.34 |
| Standard Error of the Mean |
| 0.549 |
| 2-Sided |
| 90 |
| -0.58 |
| 1.26 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.859 | Mean Difference (Final Values) | 0.09 | Standard Error of the Mean | 0.495 | 2-Sided | 90 | -0.74 | 0.92 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.467 | Mean Difference (Final Values) | -0.39 | Standard Error of the Mean | 0.526 | 2-Sided | 90 | -1.27 | 0.50 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.909 |
| Mean Difference (Final Values) |
| 0.05 |
| Standard Error of the Mean |
| 0.439 |
| 2-Sided |
| 90 |
| -0.68 |
| 0.79 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.245 | Mean Difference (Final Values) | -0.46 | Standard Error of the Mean | 0.392 | 2-Sided | 90 | -1.12 | 0.20 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.382 | Mean Difference (Final Values) | -0.36 | Standard Error of the Mean | 0.412 | 2-Sided | 90 | -1.05 | 0.33 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.688 |
| Mean Difference (Final Values) |
| 0.37 |
| Standard Error of the Mean |
| 0.908 |
| 2-Sided |
| 90 |
| -1.15 |
| 1.89 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.637 | Mean Difference (Final Values) | -0.38 | Standard Error of the Mean | 0.803 | 2-Sided | 90 | -1.73 | 0.96 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.355 | Mean Difference (Final Values) | -0.79 | Standard Error of the Mean | 0.849 | 2-Sided | 90 | -2.22 | 0.63 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.708 |
| Mean Difference (Final Values) |
| 0.19 |
| Standard Error of the Mean |
| 0.489 |
| 2-Sided |
| 90 |
| -0.65 |
| 1.02 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.166 | Mean Difference (Final Values) | 0.62 | Standard Error of the Mean | 0.434 | 2-Sided | 90 | -0.12 | 1.37 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.424 | Mean Difference (Final Values) | 0.33 | Standard Error of the Mean | 0.408 | 2-Sided | 90 | -0.37 | 1.03 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.014 |
| Mean Difference (Final Values) |
| 4.07 |
| Standard Error of the Mean |
| 1.532 |
| 2-Sided |
| 90 |
| 1.44 |
| 6.69 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.053 | Mean Difference (Final Values) | 2.85 | Standard Error of the Mean | 1.400 | 2-Sided | 90 | 0.45 | 5.25 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.012 | Mean Difference (Final Values) | 3.56 | Standard Error of the Mean | 1.299 | 2-Sided | 90 | 1.33 | 5.78 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.026 |
| Mean Difference (Final Values) |
| 4.27 |
| Standard Error of the Mean |
| 1.798 |
| 2-Sided |
| 90 |
| 1.18 |
| 7.35 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.046 | Mean Difference (Final Values) | 3.44 | Standard Error of the Mean | 1.626 | 2-Sided | 90 | 0.65 | 6.22 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.018 | Mean Difference (Final Values) | 3.86 | Standard Error of the Mean | 1.512 | 2-Sided | 90 | 1.26 | 6.45 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.092 |
| Mean Difference (Final Values) |
| 1.74 |
| Standard Error of the Mean |
| 0.988 |
| 2-Sided |
| 90 |
| 0.05 |
| 3.43 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.173 | Mean Difference (Final Values) | 1.26 | Standard Error of the Mean | 0.893 | 2-Sided | 90 | -0.28 | 2.79 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.545 | Mean Difference (Final Values) | 0.51 | Standard Error of the Mean | 0.837 | 2-Sided | 90 | -0.92 | 1.95 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.004 |
| Mean Difference (Final Values) |
| 4.71 |
| Standard Error of the Mean |
| 1.486 |
| 2-Sided |
| 90 |
| 2.16 |
| 7.26 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.088 | Mean Difference (Final Values) | 2.40 | Standard Error of the Mean | 1.350 | 2-Sided | 90 | 0.09 | 4.72 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.010 | Mean Difference (Final Values) | 3.54 | Standard Error of the Mean | 1.252 | 2-Sided | 90 | 1.39 | 5.68 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.008 |
| Mean Difference (Final Values) |
| 6.55 |
| Standard Error of the Mean |
| 2.237 |
| 2-Sided |
| 90 |
| 2.72 |
| 10.38 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.084 | Mean Difference (Final Values) | 3.65 | Standard Error of the Mean | 2.016 | 2-Sided | 90 | 0.19 | 7.10 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.041 | Mean Difference (Final Values) | 4.05 | Standard Error of the Mean | 1.871 | 2-Sided | 90 | 0.84 | 7.25 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.961 |
| Mean Difference (Final Values) |
| 0.00 |
| Standard Error of the Mean |
| 0.051 |
| 2-Sided |
| 90 |
| -0.08 |
| 0.09 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.128 | Mean Difference (Final Values) | -0.08 | Standard Error of the Mean | 0.048 | 2-Sided | 90 | -0.16 | 0.01 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.300 | Mean Difference (Final Values) | -0.05 | Standard Error of the Mean | 0.045 | 2-Sided | 90 | -0.12 | 0.03 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.226 |
| Mean Difference (Final Values) |
| 6.77 |
| Standard Error of the Mean |
| 5.519 |
| 2-Sided |
| 90 |
| -2.48 |
| 16.02 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.904 | Mean Difference (Final Values) | 0.62 | Standard Error of the Mean | 5.103 | 2-Sided | 90 | -7.94 | 9.18 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.285 | Mean Difference (Final Values) | 6.17 | Standard Error of the Mean | 5.710 | 2-Sided | 90 | -3.41 | 15.75 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.505 |
| Mean Difference (Final Values) |
| -0.37 |
| Standard Error of the Mean |
| 0.547 |
| 2-Sided |
| 90 |
| -1.28 |
| 0.55 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.743 | Mean Difference (Final Values) | 0.18 | Standard Error of the Mean | 0.540 | 2-Sided | 90 | -0.73 | 1.08 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.540 | Mean Difference (Final Values) | 0.35 | Standard Error of the Mean | 0.565 | 2-Sided | 90 | -0.60 | 1.29 | Superiority or Other (legacy) |
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. |
| ANCOVA |
| 0.006 |
| Mean Difference (Final Values) |
| 4.77 |
| Standard Error of the Mean |
| 1.662 |
| 2-Sided |
| 90 |
| 1.99 |
| 7.55 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | 0.542 | Mean Difference (Final Values) | 0.98 | Standard Error of the Mean | 1.589 | 2-Sided | 90 | -1.68 | 3.64 | Superiority or Other (legacy) |
| 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. | ANCOVA | 0.827 | Mean Difference (Final Values) | 0.36 | Standard Error of the Mean | 1.627 | 2-Sided | 90 | -2.36 | 3.08 | Superiority or Other (legacy) |