Trial Outcomes & Findings for Melatonin in Patients With Multiple Sclerosis (MS). (NCT NCT03498131)

NCT ID: NCT03498131

Last Updated: 2025-03-30

Results Overview

Changes in urinary 6-SMT in 24 hours, urine measured in nanograms per gram of creatinine

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 30 participants
• Primary outcome timeframe: Baseline (month 0), Month 3, Month 6, and Month 12
• Results posted on: 2025-03-30

Participant Flow

Participant milestones

Measure	3 mg Melatonin Subjects will receive 3 mg melatonin once a day. 3 mg Melatonin: 3 mg melatonin once each day	5 mg Melatonin Subjects will receive 5 mg melatonin once a day. 5 mg Melatonin: 5 mg Melatonin once each day
Overall Study STARTED	15	15
Overall Study COMPLETED	13	10
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Melatonin in Patients With Multiple Sclerosis (MS).

Baseline characteristics by cohort

Measure	3 mg Melatonin n=15 Participants Subjects will receive 3 mg melatonin once a day. 3 mg Melatonin: 3 mg melatonin once each day	5 mg Melatonin n=15 Participants Subjects will receive 5 mg melatonin once a day. 5 mg Melatonin: 5 mg Melatonin once each day	Total n=30 Participants Total of all reporting groups
Age, Continuous	57 Years n=93 Participants	53 Years n=4 Participants	54 Years n=27 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	11 Participants n=4 Participants	23 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=93 Participants	15 Participants n=4 Participants	30 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	15 Participants n=93 Participants	14 Participants n=4 Participants	29 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	15 Participants n=93 Participants	15 Participants n=4 Participants	30 Participants n=27 Participants
Prior MS treatment Received	15 Participants n=93 Participants	15 Participants n=4 Participants	30 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline (month 0), Month 3, Month 6, and Month 12

Population: Number analyzed in one or more rows differs from overall number analyzed due to patients withdrawing or being withdrawn throughout the course of the study. Numbers analyzed in serum and urine outcomes may differ in the numbers analyzed in the questionnaire outcomes (PSQI,MFIS,MSIS-29, PDDS-PS) due to patients completing questionnaires but samples not being collected or analyzed.

Changes in urinary 6-SMT in 24 hours, urine measured in nanograms per gram of creatinine

Outcome measures

Measure	3 mg Melatonin n=15 Participants Subjects will receive 3 mg melatonin once a day. 3 mg Melatonin: 3 mg melatonin once each day	5 mg Melatonin n=15 Participants Subjects will receive 5 mg melatonin once a day. 5 mg Melatonin: 5 mg Melatonin once each day
Urine Melatonin Levels Baseline (month 0)	19 nanograms per gram of creatinine Interval 10.0 to 55.0	22 nanograms per gram of creatinine Interval 16.0 to 91.0
Urine Melatonin Levels Month 3	925 nanograms per gram of creatinine Interval 214.0 to 1305.0	1,687 nanograms per gram of creatinine Interval 808.0 to
Urine Melatonin Levels Month 6	1,030 nanograms per gram of creatinine Interval 424.0 to	2,509 nanograms per gram of creatinine
Urine Melatonin Levels Month 12	1,020 nanograms per gram of creatinine Interval 31.0 to	4,339 nanograms per gram of creatinine Interval 653.0 to

SECONDARY outcome

Timeframe: Baseline (month 0), Month 3, Month 6, and Month 12

Population: Number analyzed in one or more rows differs from overall number analyzed due to patients withdrawing or being withdrawn throughout the course of the study.

Changes in the MFIS: Modified Fatigue Impact Scale (MFIS) is a PRO, consisting of 21 statements that describe the effect of fatigue. Subject will choose an answer (0= never to 4=always) that best describes how fatigue has affected them in the past 4 weeks. Item scores are summed to a total score. The total MFIS score ranges from 0 to 84, with three subscales: Physical range 0-36, Cognitive range 0-40, and Psychosocial range 0-8. Higher scores indicate higher level of fatigue.

Outcome measures

Measure	3 mg Melatonin n=15 Participants Subjects will receive 3 mg melatonin once a day. 3 mg Melatonin: 3 mg melatonin once each day	5 mg Melatonin n=15 Participants Subjects will receive 5 mg melatonin once a day. 5 mg Melatonin: 5 mg Melatonin once each day
Modified Fatigue Impact Scale (MFIS) MFIS Score [0-84] - Baseline	25 scores on a MFIS scale Interval 16.0 to 25.0	24 scores on a MFIS scale Interval 8.0 to 24.0
Modified Fatigue Impact Scale (MFIS) MFIS Score [0-84] - 3 months visit	16.5 scores on a MFIS scale Interval 9.5 to 16.5	22.0 scores on a MFIS scale Interval 14.5 to 22.0
Modified Fatigue Impact Scale (MFIS) MFIS Score [0-84] - 6 months visit	22 scores on a MFIS scale Interval 4.75 to 22.0	21.5 scores on a MFIS scale Interval 11.2 to 21.5
Modified Fatigue Impact Scale (MFIS) MFIS Score [0-84] - 12 months visit	20.5 scores on a MFIS scale Interval 6.0 to 20.5	19.0 scores on a MFIS scale Interval 12.0 to 19.0

SECONDARY outcome

Timeframe: Baseline (month 0), Month 3, Month 6, and Month 12

Population: Number analyzed in one or more rows differs from overall number analyzed due to patients withdrawing or being withdrawn throughout the course of the study. Numbers analyzed in serum and urine outcomes may differ in the numbers analyzed in the questionnaire outcomes (PSQI,MFIS,MSIS-29, PDDS-PS) due to patients completing questionnaires but samples not being collected or analyzed.

Changes in morning blood levels of melatonin

Outcome measures

Measure	3 mg Melatonin n=15 Participants Subjects will receive 3 mg melatonin once a day. 3 mg Melatonin: 3 mg melatonin once each day	5 mg Melatonin n=15 Participants Subjects will receive 5 mg melatonin once a day. 5 mg Melatonin: 5 mg Melatonin once each day
Serum Melatonin Level Baseline (Month 0)	5 pg/ml Interval 4.0 to 9.0	5 pg/ml Interval 4.0 to 13.0
Serum Melatonin Level Month 3	14 pg/ml Interval 8.0 to 44.0	69 pg/ml Interval 32.0 to 111.0
Serum Melatonin Level Month 6	35 pg/ml Interval 12.0 to 51.0	72 pg/ml Interval 46.0 to 193.0
Serum Melatonin Level Month 12	29 pg/ml Interval 8.0 to 56.0	97 pg/ml Interval 20.0 to 261.0

SECONDARY outcome

Timeframe: Baseline (month 0), Month 3, Month 6, and Month 12

Population: Number analyzed in one or more rows differs from overall number analyzed due to patients withdrawing or being withdrawn throughout the course of the study.

Multiple Sclerosis Impact Scale (MSIS) is a patient reported outcome (PRO) measure, consisting of two subscales- physical impact of MS (20 items) and psychological impact (9 items). It asks subject to rate the impact MS has their daily life in the past 2 weeks (1=low impact to 4=large impact). Individual item scores are summed to create a raw score, which is then transformed on a scale from 0 to 100 for each subscale. Higher scores indicate greater impact of MS on QoL.

Outcome measures

Measure	3 mg Melatonin n=15 Participants Subjects will receive 3 mg melatonin once a day. 3 mg Melatonin: 3 mg melatonin once each day	5 mg Melatonin n=15 Participants Subjects will receive 5 mg melatonin once a day. 5 mg Melatonin: 5 mg Melatonin once each day
Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical - Baseline	10 MSIS-29 Score Interval 3.0 to 10.0	9.00 MSIS-29 Score Interval 5.0 to 9.0
Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical - 3 Months Visit	4.5 MSIS-29 Score Interval 4.0 to 4.5	8.00 MSIS-29 Score Interval 4.0 to 8.0
Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical - 6 months visit	7.0 MSIS-29 Score Interval 2.5 to 7.0	5.00 MSIS-29 Score Interval 2.0 to 5.0
Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical - 12 months visit	9.00 MSIS-29 Score Interval 2.0 to 9.0	8.00 MSIS-29 Score Interval 2.0 to 8.0
Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological - Baseline	8.0 MSIS-29 Score Interval 4.5 to 8.0	14.0 MSIS-29 Score Interval 9.5 to 14.0
Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological - 3 months visit	12.5 MSIS-29 Score Interval 6.5 to 12.5	8.0 MSIS-29 Score Interval 3.0 to 8.0
Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological - 6 months visit	3.0 MSIS-29 Score Interval 3.0 to 3.0	9.50 MSIS-29 Score Interval 8.0 to 9.5
Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological - 12 months visit	8.0 MSIS-29 Score Interval 0.75 to 8.0	11.0 MSIS-29 Score Interval 6.0 to 11.0

SECONDARY outcome

Timeframe: Baseline (month 0), Month 3, Month 6, and Month 12

Population: Number analyzed in one or more rows differs from overall number analyzed due to patients withdrawing or being withdrawn throughout the course of the study.

Changes in PSQI: Pittsburgh Sleep Quality Index (PSQI) asks 10 sets of questions about sleep quality and pattern in the past month. The scale derive 7 component scores based on a 0 to 3 scale (0= no difficulty, 3=severe difficulty) which are summed to a global score (range 0 to 21). Higher scores indicates worse sleep quality.

Outcome measures

Measure	3 mg Melatonin n=15 Participants Subjects will receive 3 mg melatonin once a day. 3 mg Melatonin: 3 mg melatonin once each day	5 mg Melatonin n=15 Participants Subjects will receive 5 mg melatonin once a day. 5 mg Melatonin: 5 mg Melatonin once each day
Pittsburgh Sleep Quality Index (PSQI) PSQI Global - Base Line	7.0 PSQI Score Interval 5.5 to 7.0	6.0 PSQI Score Interval 4.5 to 6.0
Pittsburgh Sleep Quality Index (PSQI) PSQI Global - 3 month Visit	5.5 PSQI Score Interval 3.0 to 5.5	9.0 PSQI Score Interval 6.0 to 9.0
Pittsburgh Sleep Quality Index (PSQI) PSQI Global - 6 months visit	6.0 PSQI Score Interval 4.0 to 6.0	8.0 PSQI Score Interval 4.5 to 8.0
Pittsburgh Sleep Quality Index (PSQI) PSQI Global - 12 month Visit	5.0 PSQI Score Interval 2.5 to 5.0	7.0 PSQI Score Interval 5.0 to 7.0

SECONDARY outcome

Timeframe: 12 months

Number of MS relapses during study

Outcome measures

Measure	3 mg Melatonin n=15 Participants Subjects will receive 3 mg melatonin once a day. 3 mg Melatonin: 3 mg melatonin once each day	5 mg Melatonin n=15 Participants Subjects will receive 5 mg melatonin once a day. 5 mg Melatonin: 5 mg Melatonin once each day
Relapse Rate o Relapse	13 Participants	15 Participants
Relapse Rate 1 Relapse	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (month 0), Month 3, Month 6, and Month 12

Population: Number analyzed in one or more rows differs from overall number analyzed due to patients withdrawing or being withdrawn throughout the course of the study.

Changes in PDDS-PS: Patient Determined Disease Steps and Performance Scales (PDDS-PS) is a PRO for MS disease status. Performance Scales (PS) has 8 subscales: mobility range, hand function range, vision range, fatigue range, cognition range, bowel/bladder range, sensory range, and spasticity range. Subject self-classify their level of disability on a 0 to 8 scale (0=Normal to 8=Bedridden) with 8 being the most disabled for PDDS. For Performance Scales (PS) subject self-classify their level of disability on a 0 to 6 scale (0=Normal to 6=Bedridden) with 6 being the most disabled for PS - Mobility. Subject self-classify their level of disability on 0 to 5 scale (0=Normal to 5=Total Disability) with 5 being the most disabled for PS - hand function range, vision range, fatigue range, cognition range, bowel/bladder range, sensory range, and spasticity range.

Outcome measures

Measure	3 mg Melatonin n=15 Participants Subjects will receive 3 mg melatonin once a day. 3 mg Melatonin: 3 mg melatonin once each day	5 mg Melatonin n=15 Participants Subjects will receive 5 mg melatonin once a day. 5 mg Melatonin: 5 mg Melatonin once each day
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Mobility - 6 Month	0.500 scores on a PDDS-PS scale Interval 0.0 to 0.5	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Patient Determined Disease Steps - Baseline	1.0 scores on a PDDS-PS scale Interval 0.0 to 1.0	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Patient Determined Disease Steps - 3 Month Visit	1.0 scores on a PDDS-PS scale Interval 0.0 to 1.0	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Patient Determined Disease Steps - 6 Month Visit	0.50 scores on a PDDS-PS scale Interval 0.0 to 0.5	0.50 scores on a PDDS-PS scale Interval 0.0 to 0.5
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Patient Determined Disease Steps - 12 Month Visit	0.50 scores on a PDDS-PS scale Interval 0.0 to 0.5	1.0 scores on a PDDS-PS scale Interval 0.0 to 1.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Mobility - 12 Month	0 scores on a PDDS-PS scale Interval 0.0 to 0.0	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Mobility - Baseline	0 scores on a PDDS-PS scale Interval 0.0 to 0.0	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Mobility - 3 Month	0 scores on a PDDS-PS scale Interval 0.0 to 0.0	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Hand Function - Baseline	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Hand Function - 3 Month	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Hand Function - 6 Month	0.500 scores on a PDDS-PS scale Interval 0.0 to 0.5	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Hand Function - 12 Month	0.500 scores on a PDDS-PS scale Interval 0.0 to 0.5	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Vision Range - Baseline	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Vision Range - 3 Month	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Vision Range - 6 Month	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Vision Range - 12 Month	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Fatigue - Baseline	2.00 scores on a PDDS-PS scale Interval 1.0 to 2.0	2.00 scores on a PDDS-PS scale Interval 1.0 to 2.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Fatigue - 3 Month	1.00 scores on a PDDS-PS scale Interval 1.0 to 1.0	1.00 scores on a PDDS-PS scale Interval 1.0 to 1.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Fatigue - 6 Month	1.00 scores on a PDDS-PS scale Interval 1.0 to 1.0	2.00 scores on a PDDS-PS scale Interval 1.0 to 2.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Fatigue - 12 Month	1.50 scores on a PDDS-PS scale Interval 1.0 to 1.5	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Cognition Range - Baseline	1.00 scores on a PDDS-PS scale Interval 1.0 to 1.0	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Cognition Range - 3 Month	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Cognition Range - 6 Month	0.500 scores on a PDDS-PS scale Interval 0.0 to 0.5	0.500 scores on a PDDS-PS scale Interval 0.0 to 0.5
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Cognition Range - 12 Month	1.00 scores on a PDDS-PS scale Interval 1.0 to 1.0	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Bowel/Bladder Range - Baseline	1.00 scores on a PDDS-PS scale Interval 0.5 to 1.0	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Bowel/Bladder Range - 3 Month	0.500 scores on a PDDS-PS scale Interval 0.0 to 0.5	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Bowel/Bladder Range - 6 Month	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Bowel/Bladder Range - 12 Month	1.00 scores on a PDDS-PS scale Interval 0.25 to 1.0	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Sensory Range - Baseline	1.00 scores on a PDDS-PS scale Interval 0.5 to 1.0	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Sensory Range - 3 Month	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0	1.00 scores on a PDDS-PS scale Interval 1.0 to 1.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Sensory Range - 6 Month	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0	0.500 scores on a PDDS-PS scale Interval 0.0 to 0.5
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Sensory Range - 12 Month	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Spasticity - Baseline	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0	0 scores on a PDDS-PS scale Interval 0.0 to 0.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Spasticity - 3 Month	0 scores on a PDDS-PS scale Interval 0.0 to 0.0	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Spasticity - 6 Month	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0
Patient Determined Disease Steps - Performance Scale (PDDS-PS) Performance Scale - Spasticity - 12 Month	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0	1.00 scores on a PDDS-PS scale Interval 0.0 to 1.0

Adverse Events

3 mg Melatonin

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

5 mg Melatonin

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	3 mg Melatonin n=15 participants at risk Subjects will receive 3 mg melatonin once a day. 3 mg Melatonin: 3 mg melatonin once each day	5 mg Melatonin n=15 participants at risk Subjects will receive 5 mg melatonin once a day. 5 mg Melatonin: 5 mg Melatonin once each day
Cardiac disorders Near-syncope	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Cardiac disorders Pacemaker insertion	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Cardiac disorders Heart block	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.

Other adverse events

Measure	3 mg Melatonin n=15 participants at risk Subjects will receive 3 mg melatonin once a day. 3 mg Melatonin: 3 mg melatonin once each day	5 mg Melatonin n=15 participants at risk Subjects will receive 5 mg melatonin once a day. 5 mg Melatonin: 5 mg Melatonin once each day
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	33.3% 5/15 • Number of events 8 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	20.0% 3/15 • Number of events 4 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Respiratory, thoracic and mediastinal disorders FLU LIKE SYMPTOMS AFTER 2ND SHINGRIX VACCINE	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Respiratory, thoracic and mediastinal disorders Acute Sinusitis	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Respiratory, thoracic and mediastinal disorders Acute viral syndrome with ageusia	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Respiratory, thoracic and mediastinal disorders Shortness of breath	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Respiratory, thoracic and mediastinal disorders Acute non-reccurrent frontal sinusitis	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Respiratory, thoracic and mediastinal disorders Sleep Apnea	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Cardiac disorders Essential hypertension	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Endocrine disorders Type II diabetes	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Endocrine disorders NIGHT SWEATS	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Endocrine disorders Thyroid lobectomy	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Endocrine disorders Thyroid/neck nodule increasing in size	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Blood and lymphatic system disorders Elevated liver function test	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Blood and lymphatic system disorders Leukopenia	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Blood and lymphatic system disorders Worsening hypercholesterolemia	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Infections and infestations Cold Sore, Right Upper Lip	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Infections and infestations POSITIVE JCV INDEX	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Infections and infestations Shingles	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Infections and infestations COVID Infection	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Musculoskeletal and connective tissue disorders LOSS OF TONE/SORENESS, LEFT GLUTEUS MUSCLE	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Musculoskeletal and connective tissue disorders WORSENING OF LEG WEAKNESS, UPPER LEFT THIGH/QUAD, BILATERAL	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Musculoskeletal and connective tissue disorders SLIGHT DECREASE IN HAND DEXTERITY, LEFT	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Musculoskeletal and connective tissue disorders LOW BACK PINCHING SENSATION	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Musculoskeletal and connective tissue disorders BROKEN FINGER, LEFT HAND, 5TH FINGER	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Musculoskeletal and connective tissue disorders WEAKNESS, GENERALIZED	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Musculoskeletal and connective tissue disorders NECK PAIN	13.3% 2/15 • Number of events 2 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Musculoskeletal and connective tissue disorders Tenderness, left plantar surface of foot	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Musculoskeletal and connective tissue disorders DUPUYTREN'S CONTRACTURE, BILATERAL HANDS	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Musculoskeletal and connective tissue disorders Right foot pain	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Musculoskeletal and connective tissue disorders Pain, lower extremities	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Musculoskeletal and connective tissue disorders Weakness/tightness, lower extremities	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Musculoskeletal and connective tissue disorders Medial left knee pain	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Musculoskeletal and connective tissue disorders RIGHT ANKLE TENDONITIS	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Musculoskeletal and connective tissue disorders Osteopenia	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Musculoskeletal and connective tissue disorders Ankle sprain, left	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Gastrointestinal disorders Hemorrhoids	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Gastrointestinal disorders STOMACH UPSET	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Gastrointestinal disorders NAUSEA, SECONDARY TO WEAKNESS	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Gastrointestinal disorders NAUSEA	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Gastrointestinal disorders BOWEL URGENCY	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Gastrointestinal disorders Adenomatous polyp, colon	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Gastrointestinal disorders Exertional nausea	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Gastrointestinal disorders Increased Constipation	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Gastrointestinal disorders DRY MOUTH	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Eye disorders VISION CHANGES	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Gastrointestinal disorders Sore on tongue	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Gastrointestinal disorders LESION,RIGHT POSTERIOR DORSAL TONGUE	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Infections and infestations Tooth infection	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Gastrointestinal disorders Pharyngoesophageal dysphagia	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Gastrointestinal disorders tooth abscess	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Eye disorders BILATERAL RECTUS RECESSION 9.0MM W/ADJUSTABLE SUTURE, LEFT EYE	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Gastrointestinal disorders Temperature related pain, mouth	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Ear and labyrinth disorders Ear Infection	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
General disorders FATIGUE SECONDARY TO MELATONIN	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
General disorders WORSENING OF BALANCE ISSUES	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
General disorders CHILLS	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
General disorders HOT FLASHES	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
General disorders Intermittent balance issues	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
General disorders Shivering secondary to 2nd covid vaccine	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
General disorders Groggy in the mornings	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
General disorders Increased balance difficulties	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
General disorders Increased Weakness	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
General disorders Worsening increased weakness	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
General disorders Worsening increased balance difficulties	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
General disorders Increased fatigue	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
General disorders Worsening increased fatigue	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders BASAL CELL CARCINOMA, RIGHT CHEEK	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders PAIN SECONDARY TO BASAL CELL CARCINOMA REMOVAL, RIGHT CHEEK	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders BASAL CELL CARCINOMA, RIGHT CHEEK, REMOVAL	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders SENSORY DISTURBANCE RIGHT CHEEK, SECONDARY TO BASAL CELL CARCINOMA REMOVAL	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders WELL HEALED SCAR SECONDARY TO BASAL CARCINOMA REMOVAL	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders SPITZ NEVUS,RIGHT ANTERIOR LATERAL ARM, BIOPSY	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders NEOPLASM, UNSPECIFIED, BIOPSY RIGHT ANTERIOR LATERAL ARM	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders DERMATOFIBROMA, RIGHT BUTTOCK	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders LENTIGO	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders CHERRY ANGIOMA	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders XEROSIS	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders SPITZ NEVUS, RIGHT ANTERIOR LATERAL ARM	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders GIANT COMEDONE	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders SEBORRHEIC KERATOSIS	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders Rash, lower left buttocks	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders Mild edema, bilateral legs	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders Focal spongiotic dermatitis with many eosinophils	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders Worsening of rash, multiple diffuse locations	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders SKIN SPLIT BETWEEN D1 AND D2 RIGHT FOOT	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders GENERALIZED DRYNESS	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders Contact dermatitis, nose	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders Cyst removal incision infection, back	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders Cyst removal, back	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Surgical and medical procedures Epidemal inclusion cyst	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders Onychomyosis	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders Tinea pedis	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders Rash, facial	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders Scaring, extremities	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders left labial cysts	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders Toe nail fungus, right	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders General pruritus	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders Chilblains, bilateral arms	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders Squamous cell in situ, scalp	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Renal and urinary disorders POSSIBLE URINARY TRACT INFECTION	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Renal and urinary disorders POSSIBLE URINARY RETENTION	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Renal and urinary disorders INTERMITTENT IRREGULAR MENSTRUAL CYCLES	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Renal and urinary disorders IRREGULAR MENSTRUAL BLEEDING	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Renal and urinary disorders Increased urinary urgency	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Renal and urinary disorders Yeast infection	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders Cervical friability/lesion (benign)	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders vaginal prolapse	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Skin and subcutaneous tissue disorders Urinary tract infection	13.3% 2/15 • Number of events 2 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 2 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Renal and urinary disorders Intermittent Urinary Hesitancy	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Psychiatric disorders WORSENING OF FATIGUE	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Psychiatric disorders INCREASED FATIGUE	20.0% 3/15 • Number of events 3 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Psychiatric disorders IRRITABILITY	13.3% 2/15 • Number of events 2 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Psychiatric disorders WORSENING DEPRESSION	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	13.3% 2/15 • Number of events 2 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Psychiatric disorders RESTLESS SLEEP	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Psychiatric disorders SLEEP ISSUES	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Psychiatric disorders INCREASED DREAMING	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Psychiatric disorders Increased stress	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Psychiatric disorders Worsening insomnia	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Psychiatric disorders Increased anxiety	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Psychiatric disorders Intermittent sleep issues	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Psychiatric disorders SLEEP DISTURBANCES	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Psychiatric disorders ANXIETY/MOOD DISTURBANCES	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Psychiatric disorders Restless during the night, unable to fall asleep	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders TWO NEW ENHANCING BRAIN LESIONS	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders WORD FINDING ISSUES	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders RADIATING PAIN, LOW BACK DOWN RIGHT LEG	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders INTERMITTENT TINGLING BILATERAL FEET	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders CONCUSSION	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders DIZZINESS, SECONDARY TO WEAKNESS	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders Intermittent dizziness	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders Dizziness	13.3% 2/15 • Number of events 2 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders INCREASED HEADACHES	13.3% 2/15 • Number of events 2 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders INCREASED RESTLESS LEG SYNDROME	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders NUMBNESS BACK OF TONGUE	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders INTERMITTENT SENSORY DISTURBANCE, HEAD	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders Increased numbness, toes	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders Trigeminal neuralgia	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders headaches upon waking in morning	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders Worsening Memory Disorder	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders Worsening Trigeminal Neuralgia	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders Carpel tunnel, left	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.
Nervous system disorders Median Neuropathy, Left Hand	6.7% 1/15 • Number of events 1 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.	0.00% 0/15 • The period during which all adverse events and serious adverse events collected began after the informed consent is obtained and ended 30 days following the last administration of study treatment and IP assignments unblinded or study discontinuation/termination, whichever is earlier, up to 5 years.

Additional Information

Director of PBSI /WC Clinical Research Program

Providence Health & Services

Phone: (503) 216-1012

Email: Chiayi.Chen@providence.org

Results disclosure agreements

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