Trial Outcomes & Findings for Ketamine for Reduction of Alcoholic Relapse (NCT NCT02649231)

NCT ID: NCT02649231

Last Updated: 2021-10-05

Results Overview

Time line follow back

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 96 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-10-05

Participant Flow

Participant milestones

Measure	Ketamine+Psychological Therapy Ketamine with psychological therapy Ketamine: 0.8 mg/kg ketamine Psychological Therapy: Manualised relapse prevention based CBT	Ketamine+Education ketamine with alcohol education Ketamine: 0.8 mg/kg ketamine Alcohol Education: Simple education about alcohol effects	Placebo+Psychological Therapy placebo with psychological therapy Placebo: 0.9% saline Psychological Therapy: Manualised relapse prevention based CBT	Placebo+Education placebo with alcohol education Placebo: 0.9% saline Alcohol Education: Simple education about alcohol effects
Overall Study STARTED	24	24	23	25
Overall Study COMPLETED	20	21	21	23
Overall Study NOT COMPLETED	4	3	2	2

Reasons for withdrawal

Measure	Ketamine+Psychological Therapy Ketamine with psychological therapy Ketamine: 0.8 mg/kg ketamine Psychological Therapy: Manualised relapse prevention based CBT	Ketamine+Education ketamine with alcohol education Ketamine: 0.8 mg/kg ketamine Alcohol Education: Simple education about alcohol effects	Placebo+Psychological Therapy placebo with psychological therapy Placebo: 0.9% saline Psychological Therapy: Manualised relapse prevention based CBT	Placebo+Education placebo with alcohol education Placebo: 0.9% saline Alcohol Education: Simple education about alcohol effects
Overall Study Adverse Event	0	0	0	1
Overall Study Lost to Follow-up	2	1	1	0
Overall Study Withdrawal by Subject	0	1	0	1
Overall Study Protocol Violation	2	1	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Ketamine+Psychological Therapy n=24 Participants Ketamine with psychological therapy Ketamine: 0.8 mg/kg ketamine Psychological Therapy: Manualised relapse prevention based CBT	Ketamine+Education n=24 Participants ketamine with alcohol education Ketamine: 0.8 mg/kg ketamine Alcohol Education: Simple education about alcohol effects	Placebo+Psychological Therapy n=23 Participants placebo with psychological therapy Placebo: 0.9% saline Psychological Therapy: Manualised relapse prevention based CBT	Placebo+Education n=25 Participants placebo with alcohol education Placebo: 0.9% saline Alcohol Education: Simple education about alcohol effects	Total n=96 Participants Total of all reporting groups
Age, Continuous	45.2 years STANDARD_DEVIATION 8.7 • n=24 Participants	40.5 years STANDARD_DEVIATION 11.1 • n=24 Participants	47.0 years STANDARD_DEVIATION 11.8 • n=23 Participants	43.7 years STANDARD_DEVIATION 10.2 • n=25 Participants	44.1 years STANDARD_DEVIATION 10.6 • n=96 Participants
Sex: Female, Male Female	10 Participants n=24 Participants	7 Participants n=24 Participants	8 Participants n=23 Participants	10 Participants n=25 Participants	35 Participants n=96 Participants
Sex: Female, Male Male	14 Participants n=24 Participants	17 Participants n=24 Participants	15 Participants n=23 Participants	15 Participants n=25 Participants	61 Participants n=96 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	24 participants n=24 Participants	24 participants n=24 Participants	23 participants n=23 Participants	25 participants n=25 Participants	96 participants n=96 Participants

PRIMARY outcome

Timeframe: 6 months

Population: To explain discrepancies between overall number of participants analysed and the flow diagram: Only participants with a minimum of 159 days of completed drinking self-report data were included in the main analysis of alcohol relapse status as this was the shortest duration of time before any participant completed the 6 month (23-25 week) follow up in the study. Reporting time was capped at 180 days.

Time line follow back

Outcome measures

Measure	Ketamine+Psychological Therapy n=21 Participants Ketamine with psychological therapy Ketamine: 0.8 mg/kg ketamine Psychological Therapy: Manualised relapse prevention based CBT	Ketamine+Education n=22 Participants ketamine with alcohol education Ketamine: 0.8 mg/kg ketamine Alcohol Education: Simple education about alcohol effects	Placebo+Psychological Therapy n=21 Participants placebo with psychological therapy Placebo: 0.9% saline Psychological Therapy: Manualised relapse prevention based CBT	Placebo+Education n=23 Participants placebo with alcohol education Placebo: 0.9% saline Alcohol Education: Simple education about alcohol effects
Relapse Rates	13 Participants	15 Participants	14 Participants	18 Participants

PRIMARY outcome

Timeframe: 6 months

Time line follow back

Outcome measures

Measure	Ketamine+Psychological Therapy n=24 Participants Ketamine with psychological therapy Ketamine: 0.8 mg/kg ketamine Psychological Therapy: Manualised relapse prevention based CBT	Ketamine+Education n=24 Participants ketamine with alcohol education Ketamine: 0.8 mg/kg ketamine Alcohol Education: Simple education about alcohol effects	Placebo+Psychological Therapy n=23 Participants placebo with psychological therapy Placebo: 0.9% saline Psychological Therapy: Manualised relapse prevention based CBT	Placebo+Education n=25 Participants placebo with alcohol education Placebo: 0.9% saline Alcohol Education: Simple education about alcohol effects
Percentage Days Abstinent	86.4 percentage of days abstinent Standard Deviation 17.7	82.5 percentage of days abstinent Standard Deviation 20.0	78.3 percentage of days abstinent Standard Deviation 26.9	70.7 percentage of days abstinent Standard Deviation 25.1

Adverse Events

Ketamine+Psychological Therapy

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Ketamine+Education

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo+Psychological Therapy

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo+Education

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ketamine+Psychological Therapy n=24 participants at risk Ketamine with psychological therapy Ketamine: 0.8 mg/kg ketamine Psychological Therapy: Manualised relapse prevention based CBT	Ketamine+Education n=24 participants at risk ketamine with alcohol education Ketamine: 0.8 mg/kg ketamine Alcohol Education: Simple education about alcohol effects	Placebo+Psychological Therapy n=23 participants at risk placebo with psychological therapy Placebo: 0.9% saline Psychological Therapy: Manualised relapse prevention based CBT	Placebo+Education n=25 participants at risk placebo with alcohol education Placebo: 0.9% saline Alcohol Education: Simple education about alcohol effects
Injury, poisoning and procedural complications Brain hemorrhage	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Pregnancy, puerperium and perinatal conditions Abdominal pain	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Alcohol intoxication	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 3 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Infections and infestations Kidney infection	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.

Other adverse events

Measure	Ketamine+Psychological Therapy n=24 participants at risk Ketamine with psychological therapy Ketamine: 0.8 mg/kg ketamine Psychological Therapy: Manualised relapse prevention based CBT	Ketamine+Education n=24 participants at risk ketamine with alcohol education Ketamine: 0.8 mg/kg ketamine Alcohol Education: Simple education about alcohol effects	Placebo+Psychological Therapy n=23 participants at risk placebo with psychological therapy Placebo: 0.9% saline Psychological Therapy: Manualised relapse prevention based CBT	Placebo+Education n=25 participants at risk placebo with alcohol education Placebo: 0.9% saline Alcohol Education: Simple education about alcohol effects
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Respiratory, thoracic and mediastinal disorders Chest infection	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Respiratory, thoracic and mediastinal disorders Viral rhinitis	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.3% 2/24 • Number of events 4 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.7% 2/23 • Number of events 3 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	16.0% 4/25 • Number of events 4 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.0% 2/25 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Vascular disorders Hypertension	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.3% 2/24 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Surgical and medical procedures Arm pain	4.2% 1/24 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Surgical and medical procedures Dental implantation	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Surgical and medical procedures Hernia repair	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Immune system disorders Allergic reaction insect bites	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Fatigue	12.5% 3/24 • Number of events 3 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	25.0% 6/24 • Number of events 10 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	16.0% 4/25 • Number of events 7 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Influenza	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Insomnia	8.3% 2/24 • Number of events 4 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.3% 2/24 • Number of events 4 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.7% 2/23 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.0% 2/25 • Number of events 4 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Mental confusion	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.3% 2/24 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.0% 2/25 • Number of events 3 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Unsteadiness	4.2% 1/24 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.3% 2/24 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Lack of coordination	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.3% 2/24 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Ankle pain	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Chest pain	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Elbow pain	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Joint pain	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Knee pain	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Stomach pain	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Toe pain	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Cannula (for infusion) blocked	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Feeling cold	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Fever	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Hot flush	4.2% 1/24 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Psychiatric disorders Anxiety	8.3% 2/24 • Number of events 3 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	13.0% 3/23 • Number of events 3 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	12.0% 3/25 • Number of events 3 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Psychiatric disorders Depressed mood	16.7% 4/24 • Number of events 5 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	50.0% 12/24 • Number of events 15 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	30.4% 7/23 • Number of events 8 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	24.0% 6/25 • Number of events 7 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Psychiatric disorders Anger	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Psychiatric disorders Emotional distress during talking session	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Psychiatric disorders Emotionally unstable	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Psychiatric disorders Euphoric mood	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Psychiatric disorders Feelings of altered reality	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Psychiatric disorders Flat affect	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Psychiatric disorders Lethargy	4.2% 1/24 • Number of events 3 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Psychiatric disorders Loss of interest in activities	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Psychiatric disorders Mood fluctuations	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Psychiatric disorders Nervousness	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Psychiatric disorders Passive suicidal thoughts	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Psychiatric disorders Seizure during alcohol withdrawal	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
General disorders Suicidal ideation	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Psychiatric disorders Tearfulness	8.3% 2/24 • Number of events 3 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Reproductive system and breast disorders Erection	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Injury, poisoning and procedural complications Haematoma	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	16.0% 4/25 • Number of events 7 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Injury, poisoning and procedural complications Anaesthetic shivers	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Injury, poisoning and procedural complications Broken thumb	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Injury, poisoning and procedural complications Cut heel	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Injury, poisoning and procedural complications Cut finger	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Injury, poisoning and procedural complications Cut at wrist	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Injury, poisoning and procedural complications Scratch to forehead	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Injury, poisoning and procedural complications Finger fracture	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Injury, poisoning and procedural complications Hospitalisation due to morphine overdose	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Injury, poisoning and procedural complications Injured coccyx	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Injury, poisoning and procedural complications IV cannula infiltration	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Injury, poisoning and procedural complications Sprained ankle	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Injury, poisoning and procedural complications Whiplash associated disorder	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Injury, poisoning and procedural complications Wrist sprain	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Cardiac disorders Tachycardia	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Cardiac disorders Hypotension	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Respiratory, thoracic and mediastinal disorders Coughing up blood	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract infection	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Blood and lymphatic system disorders ALT and AST increase in blood test	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Blood and lymphatic system disorders Chronic lymphocytic leukaemia diagnosis	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Blood and lymphatic system disorders Low folic acid	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Blood and lymphatic system disorders Swollen glands	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Nervous system disorders Dizziness	8.3% 2/24 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.7% 2/23 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Nervous system disorders Headache	12.5% 3/24 • Number of events 6 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	16.7% 4/24 • Number of events 5 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.7% 2/23 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	32.0% 8/25 • Number of events 15 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Nervous system disorders Impaired concentration	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	16.7% 4/24 • Number of events 6 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.0% 2/25 • Number of events 3 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Nervous system disorders Memory impairment	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	12.5% 3/24 • Number of events 3 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.0% 2/25 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Nervous system disorders Altered Time perception	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Nervous system disorders Bodily numbness	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Nervous system disorders Laceration to forehead due to fall during seizure	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Nervous system disorders Restless legs syndrome	4.2% 1/24 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Nervous system disorders Migraine	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Nervous system disorders Vasovagal syncope	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Eye disorders Visual distortions	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Gastrointestinal disorders Constipation	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Gastrointestinal disorders Diarrhoea	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Gastrointestinal disorders Thirst	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Gastrointestinal disorders Loss of appetite	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Gastrointestinal disorders Nausea	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Gastrointestinal disorders Vomiting	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Hepatobiliary disorders Aspartate aminotransferase increased	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Hepatobiliary disorders Liver function test increased	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Renal and urinary disorders Cystitis	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Renal and urinary disorders Haematuria	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Skin and subcutaneous tissue disorders Skin rash arm	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.0% 2/25 • Number of events 5 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Skin and subcutaneous tissue disorders Skin rash leg	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.0% 2/25 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Skin and subcutaneous tissue disorders Dry skin	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Skin and subcutaneous tissue disorders Skin irritation	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Skin and subcutaneous tissue disorders Two red bumps around eyes	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Musculoskeletal and connective tissue disorders Back pain	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.0% 2/25 • Number of events 3 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Musculoskeletal and connective tissue disorders Muscle pain	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.7% 2/23 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Musculoskeletal and connective tissue disorders Shoulder pain	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	8.0% 2/25 • Number of events 3 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Musculoskeletal and connective tissue disorders Arthritis	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Musculoskeletal and connective tissue disorders Bursitis	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Musculoskeletal and connective tissue disorders Carpal tunnel syndrome	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Musculoskeletal and connective tissue disorders Muscle strain thorax	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Musculoskeletal and connective tissue disorders Strained gluteus maximus	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Musculoskeletal and connective tissue disorders Stiff neck	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Musculoskeletal and connective tissue disorders Toothache	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 2 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Infections and infestations Herpes labialis	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Infections and infestations Finger infection	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Infections and infestations Fungal infection	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Infections and infestations Mouth ulcer	4.2% 1/24 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.3% 1/23 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/25 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.
Infections and infestations Oral candidiasis	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/24 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	0.00% 0/23 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.	4.0% 1/25 • Number of events 1 • Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit. Participants were asked about any potential adverse events at the beginning of each visit.

Additional Information

Professor Celia Morgan

University of Exeter

Phone: 01392 724649

Email: Celia.Morgan@exeter.ac.uk

Results disclosure agreements

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