Trial Outcomes & Findings for A Study of Clenbuterol (CST-103) Co-administered With Nadolol (CST-107) in Subjects With Neurodegenerative Disorders (NCT NCT04739423)

Last Updated: 2024-12-02

Results Overview

Faces with six different basic emotions (happiness, fear, anger, disgust, sadness, surprise) are briefly displayed on a screen and participants are required to indicate the expression of the face via a button-press. Cohort A only.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

Days 7 and 14 of each Treatment Period (Two 14-day periods)

Results posted on

2024-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	PD Sequence 1 Subjects with PD enrolled in Cohort A, randomized to receive CST-103/CST-107 then Placebo	PD Sequence 2 Subjects with PD enrolled in Cohort A, randomized to receive Placebo then CST-103/CST-107	MCI Sequence 1 Subjects with MCI enrolled in Cohort A, randomised to receive CST-103/CST-107 then Placebo	MCI Sequence 2 Subjects with MCI enrolled in Cohort A, randomized to receive Placebo then CST-103/CST-107	PDD or DLB Sequence 1 Subjects with PDD or DLB enrolled in Cohort B, randomized to receive CST-103/CST-107 then Placebo	PDD or DLB Sequence 2 Subjects with PDD or DLB enrolled in Cohort B, randomized to receive Placebo then CST-103/CST-107
Overall Study STARTED	12	13	6	7	1	2
Overall Study COMPLETED	12	12	5	7	0	1
Overall Study NOT COMPLETED	0	1	1	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	PD Sequence 2 Subjects with PD enrolled in Cohort A, randomized to receive Placebo then CST-103/CST-107	MCI Sequence 1 Subjects with MCI enrolled in Cohort A, randomised to receive CST-103/CST-107 then Placebo	PDD or DLB Sequence 1 Subjects with PDD or DLB enrolled in Cohort B, randomized to receive CST-103/CST-107 then Placebo	PDD or DLB Sequence 2 Subjects with PDD or DLB enrolled in Cohort B, randomized to receive Placebo then CST-103/CST-107
Overall Study Protocol Violation	1	0	0	0
Overall Study Adverse Event	0	1	1	0
Overall Study Withdrawal by Subject	0	0	0	1

Baseline Characteristics

A Study of Clenbuterol (CST-103) Co-administered With Nadolol (CST-107) in Subjects With Neurodegenerative Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=41 Participants All subjects enrolled in study.
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized White	40 Participants n=5 Participants
Region of Enrollment New Zealand	15 participants n=5 Participants
Region of Enrollment United Kingdom	11 participants n=5 Participants
Region of Enrollment Australia	5 participants n=5 Participants
Region of Enrollment Belgium	10 participants n=5 Participants
Age, Continuous	63.7 years STANDARD_DEVIATION 7.40 • n=5 Participants

PRIMARY outcome

Timeframe: Days 7 and 14 of each Treatment Period (Two 14-day periods)

Population: Full Analysis Set (FAS) - The FAS included all randomized study subjects who had taken at least one dose of blinded study drug in this crossover study. In accordance with the protocol this outcome measure was only applicable for Cohort A. Data are presented by treatment for each patient population analyzed.

Outcome measures

Outcome measures
Measure	PD - Placebo n=23 Participants Subjects with PD enrolled in Cohort A following treatment with placebo.	PD - Active n=24 Participants Subjects with PD enrolled in Cohort A following treatment with active.	MCI - Placebo n=12 Participants Subjects with MCI enrolled in Cohort A following treatment with placebo.	MCI - Active n=12 Participants Subjects with MCI enrolled in Cohort A following treatment with active.	PDD or DLB - Placebo Subjects with PDD or DLB enrolled in Cohort B following treatment with placebo.	PDD or DLB - Active Subjects with PDD or DLB enrolled in Cohort B following treatment with active.	Overall - Placebo All subjects following treatment with placebo	Overall - Active All subjects following treatment with active
Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT) Accuracy for happiness - Change from baseline to Day 14	8.1316 Percent change Standard Error 2.5783	13.6138 Percent change Standard Error 2.5462	8.0168 Percent change Standard Error 4.9441	6.7407 Percent change Standard Error 4.9441	—	—	—	—
Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT) Accuracy for sadness - Change from baseline to Day 14	-6.9002 Percent change Standard Error 1.7950	-2.1048 Percent change Standard Error 1.7749	-7.7744 Percent change Standard Error 2.3576	-5.8789 Percent change Standard Error 2.3576	—	—	—	—
Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT) Reaction time for anger - Change from baseline to Day 7	-150.77 Percent change Standard Error 78.70	16.52 Percent change Standard Error 75.97	-17.51 Percent change Standard Error 158.55	-25.03 Percent change Standard Error 165.47	—	—	—	—

PRIMARY outcome

Timeframe: Screening, Days 1 and 14 of each Treatment Period (Two 14-day periods)

Population: All participants enrolled in Cohort B.

Dementia Cognitive Fluctuation Scale (DCFS). Number of participants with improvement relative to screening. Cohort B only.

Outcome measures

Outcome measures
Measure	PD - Placebo n=3 Participants Subjects with PD enrolled in Cohort A following treatment with placebo.	PD - Active n=2 Participants Subjects with PD enrolled in Cohort A following treatment with active.	MCI - Placebo Subjects with MCI enrolled in Cohort A following treatment with placebo.	MCI - Active Subjects with MCI enrolled in Cohort A following treatment with active.	PDD or DLB - Placebo Subjects with PDD or DLB enrolled in Cohort B following treatment with placebo.	PDD or DLB - Active Subjects with PDD or DLB enrolled in Cohort B following treatment with active.	Overall - Placebo All subjects following treatment with placebo	Overall - Active All subjects following treatment with active
Change From Baseline in Cognitive Fluctuations Length of time sleeping during day.	2 Participants	1 Participants	—	—	—	—	—	—
Change From Baseline in Cognitive Fluctuations How great is the difference between the worst and the best period of function on that day?	2 Participants	2 Participants	—	—	—	—	—	—
Change From Baseline in Cognitive Fluctuations How often is patient drowsy and lethargic during the day?	1 Participants	1 Participants	—	—	—	—	—	—
Change From Baseline in Cognitive Fluctuations Overall, how would you rate the patient's level of consciousness on a usual day?	2 Participants	2 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 1, 7, 14 of each Treatment Period (Two 14-day periods)

Population: Full Analysis Set (FAS) - The FAS included all randomized study subjects who had taken at least one dose of blinded study drug. Data are presented by treatment for each patient population analyzed.

The CANTAB cognitive assessments consists of a series of interrelated computerized tests of memory, attention, and executive function, administered via a touch sensitive screen. This includes the immediate and delayed Verbal Recognition Memory (VRM) recall and recognition tests that measure the ability to encode and subsequently retrieve verbal information.

Outcome measures

Outcome measures
Measure	PD - Placebo n=25 Participants Subjects with PD enrolled in Cohort A following treatment with placebo.	PD - Active n=25 Participants Subjects with PD enrolled in Cohort A following treatment with active.	MCI - Placebo n=13 Participants Subjects with MCI enrolled in Cohort A following treatment with placebo.	MCI - Active n=13 Participants Subjects with MCI enrolled in Cohort A following treatment with active.	PDD or DLB - Placebo n=3 Participants Subjects with PDD or DLB enrolled in Cohort B following treatment with placebo.	PDD or DLB - Active n=3 Participants Subjects with PDD or DLB enrolled in Cohort B following treatment with active.	Overall - Placebo All subjects following treatment with placebo	Overall - Active All subjects following treatment with active
Change From Baseline in CANTAB Cognitive Assessments Immediate Word Recall: Number of words - Change from Baseline to Day 1, 4 hours post dose	-0.50 Words Standard Error 0.375	0.18 Words Standard Error 0.385	0.89 Words Standard Error 0.531	0.83 Words Standard Error 0.514	-1.96 Words Standard Error 0.474	-0.12 Words Standard Error 0.514	—	—
Change From Baseline in CANTAB Cognitive Assessments Immediate Word Recall: Number of words - Change from Baseline to Day 14, 4 hours post dose	0.20 Words Standard Error 0.380	1.32 Words Standard Error 0.380	1.89 Words Standard Error 0.531	1.65 Words Standard Error 0.530	-2.79 Words Standard Error 0.514	-1.29 Words Standard Error 0.514	—	—
Change From Baseline in CANTAB Cognitive Assessments Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post dose	-2.50 Words Standard Error 0.556	-0.78 Words Standard Error 0.572	0.64 Words Standard Error 0.824	0.59 Words Standard Error 0.770	-1.44 Words Standard Error 0.431	0.51 Words Standard Error 0.518	—	—
Change From Baseline in CANTAB Cognitive Assessments Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post dose	-1.17 Words Standard Error 0.572	0.13 Words Standard Error 0.564	0.37 Words Standard Error 0.776	1.34 Words Standard Error 0.775	1.01 Words Standard Error 0.518	0.01 Words Standard Error 0.518	—	—
Change From Baseline in CANTAB Cognitive Assessments Delayed Word Recognition: number of words - Change from Baseline to Day 7, 4 hrs post-dose	-1.94 Words Standard Error 0.474	-0.24 Words Standard Error 0.466	-0.44 Words Standard Error 0.891	0.40 Words Standard Error 0.889	-3.67 Words Standard Error 1.109	-6.17 Words Standard Error 1.109	—	—

SECONDARY outcome

Timeframe: Screening, Days 1-14 of each Treatment Period (Two 14-day periods)

Population: Per protocol, the BioStamp wearable device was used in a substudy that included only the clinical sites based in Australia and New Zealand. There were a total of 18 subjects in this substudy. However, only 9 subjects provided a dataset that could be analyzed for treatment effect (ie. that included baseline data and end of study period data). Data are presented by treatment for each patient population.

A wireless device that measures physical activity and sleep while at home.

Outcome measures

Outcome measures
Measure	PD - Placebo n=7 Participants Subjects with PD enrolled in Cohort A following treatment with placebo.	PD - Active n=8 Participants Subjects with PD enrolled in Cohort A following treatment with active.	MCI - Placebo Subjects with MCI enrolled in Cohort A following treatment with placebo.	MCI - Active Subjects with MCI enrolled in Cohort A following treatment with active.	PDD or DLB - Placebo Subjects with PDD or DLB enrolled in Cohort B following treatment with placebo.	PDD or DLB - Active Subjects with PDD or DLB enrolled in Cohort B following treatment with active.	Overall - Placebo n=9 Participants All subjects following treatment with placebo	Overall - Active n=9 Participants All subjects following treatment with active
Digital Wearable Device (BioStamp) - Sleeping Heart Rate	-0.39 beats per minute Standard Error 0.466	4.59 beats per minute Standard Error 0.480	—	—	—	—	-0.39 beats per minute Standard Error 0.394	4.67 beats per minute Standard Error 0.405

SECONDARY outcome

Timeframe: Screening, Days 1-14 of each Treatment Period (Two 14-day periods)

A wireless device that measures physical activity and sleep while at home.

Outcome measures

Outcome measures
Measure	PD - Placebo n=7 Participants Subjects with PD enrolled in Cohort A following treatment with placebo.	PD - Active n=8 Participants Subjects with PD enrolled in Cohort A following treatment with active.	MCI - Placebo Subjects with MCI enrolled in Cohort A following treatment with placebo.	MCI - Active Subjects with MCI enrolled in Cohort A following treatment with active.	PDD or DLB - Placebo Subjects with PDD or DLB enrolled in Cohort B following treatment with placebo.	PDD or DLB - Active Subjects with PDD or DLB enrolled in Cohort B following treatment with active.	Overall - Placebo n=9 Participants All subjects following treatment with placebo	Overall - Active n=9 Participants All subjects following treatment with active
Digital Wearable Device (BioStamp) - Sleeping Heart Rate Variability (HRV)	-0.26 ratio Standard Error 0.325	0.74 ratio Standard Error 0.330	—	—	—	—	-0.18 ratio Standard Error 0.324	0.82 ratio Standard Error 0.329

SECONDARY outcome

Timeframe: Screening, Days 1-14 of each Treatment Period (Two 14-day periods)

A wireless device that measures physical activity and sleep while at home.

Outcome measures

Outcome measures
Measure	PD - Placebo n=7 Participants Subjects with PD enrolled in Cohort A following treatment with placebo.	PD - Active n=8 Participants Subjects with PD enrolled in Cohort A following treatment with active.	MCI - Placebo Subjects with MCI enrolled in Cohort A following treatment with placebo.	MCI - Active Subjects with MCI enrolled in Cohort A following treatment with active.	PDD or DLB - Placebo Subjects with PDD or DLB enrolled in Cohort B following treatment with placebo.	PDD or DLB - Active Subjects with PDD or DLB enrolled in Cohort B following treatment with active.	Overall - Placebo n=9 Participants All subjects following treatment with placebo	Overall - Active n=9 Participants All subjects following treatment with active
Digital Wearable Device (BioStamp) - Sleeping Heart Rate Variability (HRV) - Root Mean Square of Successive Differences (RMSSD)	2.40 RMSSD Standard Error 3.101	-7.41 RMSSD Standard Error 3.184	—	—	—	—	-1.16 RMSSD Standard Error 3.229	-11.37 RMSSD Standard Error 3.292

Adverse Events

PD - Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

PD - Active

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

MCI - Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

MCI - Active

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

PDD and DLB - Placebo

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

PDD and DLB - Active

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PD - Placebo n=25 participants at risk Subjects with PD enrolled in Cohort A receiving placebo.	PD - Active n=24 participants at risk Subjects with PD enrolled in Cohort A receiving active.	MCI - Placebo n=12 participants at risk Subjects with MCI enrolled in Cohort A receiving placebo.	MCI - Active n=13 participants at risk Subjects with MCI enrolled in Cohort A receiving active.	PDD and DLB - Placebo n=3 participants at risk Subjects with PDD or DLB enrolled in Cohort B receiving placebo.	PDD and DLB - Active n=2 participants at risk Subjects with PDD or DLB enrolled in Cohort B receiving active.
Nervous system disorders Hypoglycaemic seizure	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • Number of events 1 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Blood and lymphatic system disorders Anaemia	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	33.3% 1/3 • Number of events 1 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.

Other adverse events

Other adverse events
Measure	PD - Placebo n=25 participants at risk Subjects with PD enrolled in Cohort A receiving placebo.	PD - Active n=24 participants at risk Subjects with PD enrolled in Cohort A receiving active.	MCI - Placebo n=12 participants at risk Subjects with MCI enrolled in Cohort A receiving placebo.	MCI - Active n=13 participants at risk Subjects with MCI enrolled in Cohort A receiving active.	PDD and DLB - Placebo n=3 participants at risk Subjects with PDD or DLB enrolled in Cohort B receiving placebo.	PDD and DLB - Active n=2 participants at risk Subjects with PDD or DLB enrolled in Cohort B receiving active.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	8.3% 1/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
General disorders Asthenia	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	50.0% 1/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Nervous system disorders Headache	12.0% 3/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	20.8% 5/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	15.4% 2/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Nervous system disorders Tremor	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	25.0% 6/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Nervous system disorders Memory impairment	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Nervous system disorders Parkinson's disease	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	50.0% 1/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Nervous system disorders Restless legs syndrome	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	50.0% 1/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Nervous system disorders Somnolence	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	7.7% 1/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Nervous system disorders Cognitive disorder	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Nervous system disorders Dizziness	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Nervous system disorders Essential tremor	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	7.7% 1/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Nervous system disorders Hypotonia	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	7.7% 1/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Nervous system disorders Lethargy	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Nervous system disorders Migraine	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	7.7% 1/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Nervous system disorders Parkinsonian rest tremor	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Nervous system disorders Vertebral artery anuerysm	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Psychiatric disorders Nervousness	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	15.4% 2/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Psychiatric disorders Anxiety	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	15.4% 2/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Psychiatric disorders Rapid eye movement sleep behaviour disorder	8.0% 2/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Psychiatric disorders Agitation	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	8.3% 1/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Psychiatric disorders Confusional state	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	33.3% 1/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Psychiatric disorders Depressed mood	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	50.0% 1/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Psychiatric disorders Hallucination olfactory	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Psychiatric disorders Initial insomnia	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Psychiatric disorders Insomnia	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	7.7% 1/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Psychiatric disorders Irritability	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	33.3% 1/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Psychiatric disorders Mood altered	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Psychiatric disorders Nightmare	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Psychiatric disorders Restlessness	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Psychiatric disorders Sleep disorder	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Skin and subcutaneous tissue disorders Erythema	8.0% 2/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	16.7% 4/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	50.0% 1/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	12.5% 3/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Skin and subcutaneous tissue disorders Dermatitis contact	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	8.3% 1/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Skin and subcutaneous tissue disorders Rash	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Gastrointestinal disorders Diarrhoea	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	8.3% 1/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	7.7% 1/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Gastrointestinal disorders Nausea	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	8.3% 2/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Gastrointestinal disorders Abdominal pain upper	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Gastrointestinal disorders Flatulence	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Gastrointestinal disorders Gastritis	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	7.7% 1/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Gastrointestinal disorders Stomatitis	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Gastrointestinal disorders Vomiting	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Vascular disorders Hypertension	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	8.3% 1/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	7.7% 1/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Vascular disorders Hot flush	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	8.3% 1/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Vascular disorders Orthostatic hypotension	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	33.3% 1/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Vascular disorders Supine hypertension	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Infections and infestations Gastroenteritis viral	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Infections and infestations Herpes zoster	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Infections and infestations Respiratory tract infection	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Infections and infestations Tooth infection	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Infections and infestations Upper respiratory tract infection	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	8.3% 1/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Infections and infestations Viral infection	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Investigations Blood creatine phosphokinase increased	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	7.7% 1/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Investigations Lipase increased	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Investigations Aspartate aminotransferase increased	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	50.0% 1/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Investigations Hepatic enzyme increased	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Musculoskeletal and connective tissue disorders Groin pain	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	7.7% 1/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
General disorders Malaise	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	7.7% 1/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
General disorders Oedema	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	33.3% 1/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Injury, poisoning and procedural complications Fall	8.0% 2/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Injury, poisoning and procedural complications Contusion	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Injury, poisoning and procedural complications Head injury	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Injury, poisoning and procedural complications Skin laceration	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	33.3% 1/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Cardiac disorders Tachycardia	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	7.7% 1/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Eye disorders Eye oedema	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Eye disorders Vision blurred	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Ear and labyrinth disorders Deafness	4.0% 1/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/25 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	4.2% 1/24 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/12 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/13 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/3 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.	0.00% 0/2 • From first dose to end of study visit (approximately 8 weeks). AEs may have been reported by the subject, discovered through Investigator questioning, or detected through physical examination, laboratory test, or other means.

Additional Information

Clinical Trial Information Desk

CuraSen Therapeutics, Inc

Phone: +1 650 475 2842

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place