Trial Outcomes & Findings for Fixed or Self-Titrated Dosages of Sativex on Cannabis Users (NCT NCT01748799)

NCT ID: NCT01748799

Last Updated: 2016-02-01

Results Overview

Feasibility will be assessed by analysing how many participants can be recruited/complete the whole (randomly assigned) experimental sequence with a period of one year.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2016-02-01

Participant Flow

Participant milestones

Measure	Sequence 1 Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo	Sequence 2 Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo	Sequence 3 Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex	Sequence 4 Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex	Sequence 5 Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo	Sequence 6 Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex	Sequence 7 Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex	Sequence 8 Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
Overall Study STARTED	6	1	1	2	1	2	2	1
Overall Study Completed SAU of Fixed Dose Placebo	2	1	1	2	1	1	1	1
Overall Study Completed Fixed Dose Placebo	2	1	1	2	1	1	1	1
Overall Study Completed SAU of Fixed Dose Sativex	1	1	1	2	1	1	1	1
Overall Study Completed Fixed Dose Sativex	1	1	1	2	1	1	1	1
Overall Study Completed SAU of Self-titrated Placebo	5	1	1	2	1	2	1	1
Overall Study Completed Self-titrated Placebo	4	1	1	2	1	2	1	1
Overall Study Completed SAU of Self-titrated Sativex	2	1	1	2	1	2	1	1
Overall Study Completed Self-titrated Sativex	1	1	1	2	1	1	1	1
Overall Study COMPLETED	1	1	1	2	1	1	1	1
Overall Study NOT COMPLETED	5	0	0	0	0	1	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

Baseline characteristics by cohort

Measure	Sequence 1 n=6 Participants Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo	Sequence 2 n=1 Participants Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo	Sequence 3 n=1 Participants Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex	Sequence 4 n=2 Participants Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex	Sequence 5 n=1 Participants Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo	Sequence 6 n=2 Participants Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex	Sequence 7 n=2 Participants Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex	Sequence 8 n=1 Participants Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo	Total n=16 Participants Total of all reporting groups
Age, Continuous	35.7 years STANDARD_DEVIATION 8.6 • n=93 Participants	24.0 years STANDARD_DEVIATION 0.0 • n=4 Participants	19.0 years STANDARD_DEVIATION 0.0 • n=27 Participants	46.5 years STANDARD_DEVIATION 6.4 • n=483 Participants	36.0 years STANDARD_DEVIATION 0.0 • n=36 Participants	41.5 years STANDARD_DEVIATION 6.4 • n=10 Participants	43.0 years STANDARD_DEVIATION 5.6 • n=115 Participants	22.0 years STANDARD_DEVIATION 0.0 • n=40 Participants	34.8 years STANDARD_DEVIATION 10.5 • n=8 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=40 Participants	4 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants	1 Participants n=36 Participants	2 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=40 Participants	12 Participants n=8 Participants
Region of Enrollment Canada	6 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants	2 participants n=483 Participants	1 participants n=36 Participants	2 participants n=10 Participants	2 participants n=115 Participants	1 participants n=40 Participants	16 participants n=8 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 16 participants were enrolled in the study, 9 participants completed the whole (randomly assigned) experimental sequence

Feasibility will be assessed by analysing how many participants can be recruited/complete the whole (randomly assigned) experimental sequence with a period of one year.

Outcome measures

Measure	Sequence 1 n=6 Participants Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo	Sequence 2 n=1 Participants Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo	Sequence 3 n=1 Participants Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex	Sequence 4 n=2 Participants Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex	Sequence 5 n=1 Participants Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo	Sequence 6 n=2 Participants Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex	Sequence 7 n=2 Participants Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex	Sequence 8 n=1 Participants Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
Feasibility	1 participants	1 participants	1 participants	2 participants	1 participants	1 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Data from 16 participants enrolled in the study was analyzed, none of the participants withdrew due non-tolerability of Sativex

To assess what number of participants might withdrew due non-tolerability of Sativex

Outcome measures

Measure	Sequence 1 n=6 Participants Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo	Sequence 2 n=1 Participants Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo	Sequence 3 n=1 Participants Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex	Sequence 4 n=2 Participants Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex	Sequence 5 n=1 Participants Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo	Sequence 6 n=2 Participants Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex	Sequence 7 n=2 Participants Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex	Sequence 8 n=1 Participants Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
Tolerability of Sativex in Persons That Are Cannabis Dependent	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Only 9 of the 16 participants recruited completed the whole experimental sequence (participants were assigned to 1 of 8 different experimental sequences in a randomized order).

Withdrawal symptoms were assessed using the Cannabis Withdrawal Scale (CWS) (Minimum-Maximum Scores 0-190, high scores represent more withdrawal) and Cannabis Withdrawal Checklist (CWC) (Minimum-Maximum Scores 0-48, high scores represent more withdrawal) by establishing comparisons between Sativex/Placebo and Smoke as usual conditions (4 interventions: Fixed Sativex, Fixed Placebo, Self-titrated Sativex, Self-titrated Placebo and 4 corresponding Smoke as usual conditions).

Outcome measures

Measure	Sequence 1 n=9 Participants Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo	Sequence 2 n=9 Participants Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo	Sequence 3 n=9 Participants Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex	Sequence 4 n=9 Participants Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex	Sequence 5 n=9 Participants Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo	Sequence 6 n=9 Participants Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex	Sequence 7 n=9 Participants Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex	Sequence 8 n=9 Participants Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
Cannabis Withdrawal Cannabis Withdrawal Scale (CWS)	10.3 units on a scale Standard Deviation 12.2	7.9 units on a scale Standard Deviation 10.0	9.8 units on a scale Standard Deviation 10.9	6.6 units on a scale Standard Deviation 5.8	17.9 units on a scale Standard Deviation 15.9	8.6 units on a scale Standard Deviation 11.4	13.7 units on a scale Standard Deviation 14.5	7.5 units on a scale Standard Deviation 8.3
Cannabis Withdrawal Cannabis Withdrawal Checklist (CWC) Total	3.6 units on a scale Standard Deviation 3.5	2.6 units on a scale Standard Deviation 2.0	4.0 units on a scale Standard Deviation 4.2	2.3 units on a scale Standard Deviation 2.2	7.4 units on a scale Standard Deviation 5.9	3.7 units on a scale Standard Deviation 3.4	5.9 units on a scale Standard Deviation 5.5	3.0 units on a scale Standard Deviation 1.6

Adverse Events

Fixed Dose Sativex

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Smoke as Usual FS

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Self-titrated Sativex

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Smoke as Usual StS

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Fixed Dose Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Smoke as Usual FP

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Self-titrated Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Smoke as Usual StP

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fixed Dose Sativex n=9 participants at risk Participants were requested to abstain from using cannabis and take a fixed dose of Sativex during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).	Smoke as Usual FS n=9 participants at risk Smoke as usual condition corresponding to Fixed Sativex	Self-titrated Sativex n=9 participants at risk Participants were requested to abstain from using cannabis and self-titrate dosages of Sativex (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).	Smoke as Usual StS n=11 participants at risk Smoke as usual condition corresponding to Self-titrated Sativex	Fixed Dose Placebo n=10 participants at risk Participants were requested to abstain from using cannabis and take a fixed dose of placebo during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).	Smoke as Usual FP n=10 participants at risk Smoke as usual condition corresponding to Fixed placebo	Self-titrated Placebo n=13 participants at risk Participants were requested to abstain from using cannabis and self-titrate dosages of placebo (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).	Smoke as Usual StP n=14 participants at risk Smoke as usual condition corresponding to Self-titrated placebo
Gastrointestinal disorders Nausea	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	33.3% 3/9 • Number of events 3 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/11 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	10.0% 1/10 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/13 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/14 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Psychiatric disorders Insomnia	11.1% 1/9 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	11.1% 1/9 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/11 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	30.0% 3/10 • Number of events 3 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	7.7% 1/13 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	7.1% 1/14 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Gastrointestinal disorders Diarrhea	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	22.2% 2/9 • Number of events 2 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/11 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/13 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	28.6% 4/14 • Number of events 4 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Respiratory, thoracic and mediastinal disorders Cold	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/11 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	10.0% 1/10 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	30.0% 3/10 • Number of events 3 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	23.1% 3/13 • Number of events 3 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/14 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Psychiatric disorders Nightmares	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	9.1% 1/11 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	10.0% 1/10 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/13 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/14 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Musculoskeletal and connective tissue disorders Pain in the knee	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	11.1% 1/9 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/11 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	7.7% 1/13 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/14 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Musculoskeletal and connective tissue disorders Scapula pain	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/11 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	10.0% 1/10 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/13 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/14 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Musculoskeletal and connective tissue disorders Sore foot	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	11.1% 1/9 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	9.1% 1/11 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/13 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/14 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Respiratory, thoracic and mediastinal disorders Sore Throat	11.1% 1/9 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/11 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	7.7% 1/13 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/14 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
General disorders Headache	11.1% 1/9 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/11 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	10.0% 1/10 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	10.0% 1/10 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	23.1% 3/13 • Number of events 3 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	7.1% 1/14 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Blood and lymphatic system disorders hot flashes	11.1% 1/9 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/11 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	10.0% 1/10 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	7.7% 1/13 • Number of events 2 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/14 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
General disorders Impaired taste sensation of food	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/11 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	10.0% 1/10 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	7.7% 1/13 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/14 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
General disorders Vertigo	11.1% 1/9 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	11.1% 1/9 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	9.1% 1/11 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	10.0% 1/10 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/13 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/14 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Gastrointestinal disorders heartburn	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/11 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	15.4% 2/13 • Number of events 2 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/14 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/11 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	20.0% 2/10 • Number of events 2 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/13 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/14 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Skin and subcutaneous tissue disorders Rash	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/11 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	15.4% 2/13 • Number of events 2 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	7.1% 1/14 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Ear and labyrinth disorders Ringing ears	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	11.1% 1/9 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	9.1% 1/11 • Number of events 2 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/13 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/14 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Psychiatric disorders Low motivation	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	9.1% 1/11 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/13 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/14 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Eye disorders Dry eyes	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/11 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	7.7% 1/13 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/14 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Respiratory, thoracic and mediastinal disorders Runny nose	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	11.1% 1/9 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/11 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/13 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	7.1% 1/14 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Musculoskeletal and connective tissue disorders Ankle pain	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/11 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/13 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	7.1% 1/14 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Psychiatric disorders Anxiety	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	9.1% 1/11 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/13 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	7.1% 1/14 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
General disorders Feeling drowsy	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/11 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	7.7% 1/13 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	7.1% 1/14 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.
Gastrointestinal disorders Stomach Pain	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/9 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	9.1% 1/11 • Number of events 1 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/10 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/13 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.	0.00% 0/14 • 8 weeks Some adverse events were not study-related (e.g. mild cold, tension headache or hot flashes) and some expected side effects, such as nausea, sleep problems or diarrhea, were noted.

Additional Information

Bernard Le Foll

Centre for Addiction and Mental Health (CAMH)

Phone: 416.535.8501

Email: bernard.lefoll@camh.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place