Trial Outcomes & Findings for N-Acetylcysteine for Youth Cannabis Use Disorder (NCT NCT03055377)

NCT ID: NCT03055377

Last Updated: 2024-12-17

Results Overview

Qualitative urine cannabinoid testing, with cutoff of 50 ng/mL

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 192 participants
• Primary outcome timeframe: Weekly urine cannabinoid tests during 12-week active treatment
• Results posted on: 2024-12-17

Participant Flow

Participant milestones

Measure	N-acetylcysteine N-acetylcysteine 1200 mg twice daily for 12 weeks N-acetyl cysteine: N-acetylcysteine 1200 mg twice daily for 12 weeks (administered orally)	Placebo Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks Placebo oral capsule: Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)
Treatment Phase STARTED	98	94
Treatment Phase COMPLETED	70	70
Treatment Phase NOT COMPLETED	28	24
Post-Treatment Follow-Up STARTED	70	70
Post-Treatment Follow-Up COMPLETED	44	49
Post-Treatment Follow-Up NOT COMPLETED	26	21

Reasons for withdrawal

Measure	N-acetylcysteine N-acetylcysteine 1200 mg twice daily for 12 weeks N-acetyl cysteine: N-acetylcysteine 1200 mg twice daily for 12 weeks (administered orally)	Placebo Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks Placebo oral capsule: Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)
Treatment Phase Lost to Follow-up	28	24
Post-Treatment Follow-Up Lost to Follow-up	26	21

Baseline Characteristics

N-Acetylcysteine for Youth Cannabis Use Disorder

Baseline characteristics by cohort

Measure	N-acetylcysteine n=98 Participants N-acetylcysteine 1200 mg twice daily for 12 weeks N-acetyl cysteine: N-acetylcysteine 1200 mg twice daily for 12 weeks (administered orally)	Placebo n=94 Participants Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks Placebo oral capsule: Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)	Total n=192 Participants Total of all reporting groups
Age, Continuous	19.1 years STANDARD_DEVIATION 1.3 • n=5 Participants	19.2 years STANDARD_DEVIATION 1.7 • n=7 Participants	19.2 years STANDARD_DEVIATION 1.5 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	46 Participants n=7 Participants	101 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	48 Participants n=7 Participants	91 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=5 Participants	83 Participants n=7 Participants	165 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	78 Participants n=5 Participants	73 Participants n=7 Participants	151 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	98 participants n=5 Participants	94 participants n=7 Participants	192 participants n=5 Participants

PRIMARY outcome

Timeframe: Weekly urine cannabinoid tests during 12-week active treatment

Population: Enrolled and randomized participants

Qualitative urine cannabinoid testing, with cutoff of 50 ng/mL

Outcome measures

Measure	N-acetylcysteine n=763 Urine cannabinoid tests N-acetylcysteine 1200 mg twice daily for 12 weeks N-acetyl cysteine: N-acetylcysteine 1200 mg twice daily for 12 weeks (administered orally)	Placebo n=785 Urine cannabinoid tests Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks Placebo oral capsule: Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)
Percentage of Urine Tests With Negative Cannabinoid Results During Treatment	9.4 Percentage	14.0 Percentage

Adverse Events

N-acetylcysteine

Serious events: 0 serious events

Other events: 86 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 73 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	N-acetylcysteine n=98 participants at risk N-acetylcysteine 1200 mg twice daily for 12 weeks N-acetyl cysteine: N-acetylcysteine 1200 mg twice daily for 12 weeks (administered orally)	Placebo n=94 participants at risk Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks Placebo oral capsule: Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)
Cardiac disorders Palpitations	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Blood and lymphatic system disorders Lymphadenopathy	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Ear and labyrinth disorders Ear Congestion	2.0% 2/98 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Ear and labyrinth disorders Otitis Media	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Eye disorders Conjunctivitis	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Eye disorders Eyebrow Twitching	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Gastrointestinal disorders Abdominal Pain	3.1% 3/98 • Number of events 3 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	5.3% 5/94 • Number of events 5 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Gastrointestinal disorders Decreased Appetite	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Gastrointestinal disorders Diarrhea	5.1% 5/98 • Number of events 6 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	8.5% 8/94 • Number of events 8 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Gastrointestinal disorders Dyspepsia	10.2% 10/98 • Number of events 14 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	5.3% 5/94 • Number of events 7 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Gastrointestinal disorders Flatulence	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Gastrointestinal disorders Gastritis	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Gastrointestinal disorders Gastroenteritis	5.1% 5/98 • Number of events 5 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	2.1% 2/94 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Gastrointestinal disorders Gastroesophageal Reflux Disease	14.3% 14/98 • Number of events 16 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	3.2% 3/94 • Number of events 4 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Gastrointestinal disorders Heartburn	3.1% 3/98 • Number of events 3 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Gastrointestinal disorders Nausea	32.7% 32/98 • Number of events 41 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	17.0% 16/94 • Number of events 22 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Gastrointestinal disorders Stomachache	7.1% 7/98 • Number of events 9 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	4.3% 4/94 • Number of events 5 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Gastrointestinal disorders Vomiting	16.3% 16/98 • Number of events 19 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	9.6% 9/94 • Number of events 12 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
General disorders Chills	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
General disorders Drug Withdrawal Syndrome	1.0% 1/98 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	2.1% 2/94 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
General disorders Early Satiety	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
General disorders Fatigue	3.1% 3/98 • Number of events 3 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	2.1% 2/94 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
General disorders Hangover	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
General disorders Malaise	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
General disorders Tired	2.0% 2/98 • Number of events 3 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
General disorders Chest Pain	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Immune system disorders Allergy to Animals	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Infections and infestations Coronavirus Infection	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	3.2% 3/94 • Number of events 4 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Immune system disorders Immunization Reaction	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Immune system disorders Rhinitis Seasonal (Worsening)	2.0% 2/98 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Infections and infestations Abscess	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Infections and infestations Acarodermatitis	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Infections and infestations Bronchitis	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Infections and infestations Hordeolum	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Infections and infestations Influenza	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Infections and infestations Influenza Like Illness	2.0% 2/98 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	3.2% 3/94 • Number of events 3 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Infections and infestations Nasopharyngitis	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Infections and infestations Otitis Media	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	2.1% 2/94 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Infections and infestations Pharyngitis	4.1% 4/98 • Number of events 4 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	2.1% 2/94 • Number of events 3 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Infections and infestations Pharyngitis Streptococcal	2.0% 2/98 • Number of events 3 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Infections and infestations Pyrexia	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Infections and infestations Sinusitis	5.1% 5/98 • Number of events 7 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	4.3% 4/94 • Number of events 4 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Infections and infestations Tinea Cruris	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Infections and infestations Tonsillitis	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Infections and infestations Urinary Tract Infection	1.0% 1/98 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	2.1% 2/94 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Infections and infestations Viral Upper Respiratory Tract Infection	23.5% 23/98 • Number of events 30 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	28.7% 27/94 • Number of events 36 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Injury, poisoning and procedural complications Allergy to arthropod bite	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Injury, poisoning and procedural complications Animal Bite	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	2.1% 2/94 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Injury, poisoning and procedural complications Back Pain	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Injury, poisoning and procedural complications Concussion	2.0% 2/98 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Injury, poisoning and procedural complications Head Injury	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Injury, poisoning and procedural complications Post-traumatic pain	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Injury, poisoning and procedural complications Road Traffic Accident	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Injury, poisoning and procedural complications Sprained Ankle	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Injury, poisoning and procedural complications Sunburn	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Investigations Sputum Abnormal	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Investigations Weight Decrease	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Metabolism and nutrition disorders Abnormal Weight Loss	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Metabolism and nutrition disorders Decreased Appetite	9.2% 9/98 • Number of events 9 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	7.4% 7/94 • Number of events 7 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Metabolism and nutrition disorders Early Satiety	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Metabolism and nutrition disorders Food Intolerance	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Metabolism and nutrition disorders Glucose Tolerance Impaired	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Metabolism and nutrition disorders Increased Appetite	2.0% 2/98 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Musculoskeletal and connective tissue disorders Back Pain	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Musculoskeletal and connective tissue disorders Joint Dislocation	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Musculoskeletal and connective tissue disorders Joint Stiffness	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Musculoskeletal and connective tissue disorders Limb Injury	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Musculoskeletal and connective tissue disorders Muscle Weakness	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Musculoskeletal and connective tissue disorders Myalgia	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Musculoskeletal and connective tissue disorders Neck Swelling	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Musculoskeletal and connective tissue disorders Pain in Extremity	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	3.2% 3/94 • Number of events 3 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Musculoskeletal and connective tissue disorders Plantar Fasciitis	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Nervous system disorders Dizziness	4.1% 4/98 • Number of events 4 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	4.3% 4/94 • Number of events 5 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Nervous system disorders Dysgeusia	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Nervous system disorders Dyskinesia	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Nervous system disorders Headache	25.5% 25/98 • Number of events 30 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	17.0% 16/94 • Number of events 18 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Nervous system disorders Irritability	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Nervous system disorders Migraine	2.0% 2/98 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Nervous system disorders Paresthesia	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Nervous system disorders Poor Quality Sleep	3.1% 3/98 • Number of events 3 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Nervous system disorders Somnolence	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Nervous system disorders Syncope	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Nervous system disorders Taste Disorder	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Psychiatric disorders Abnormal Dreams	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Psychiatric disorders Agitation	1.0% 1/98 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Psychiatric disorders Anxiety	5.1% 5/98 • Number of events 6 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	11.7% 11/94 • Number of events 12 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Psychiatric disorders ADHD	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Psychiatric disorders Depressed Mood	2.0% 2/98 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	8.5% 8/94 • Number of events 9 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Psychiatric disorders Hypersomnia	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Psychiatric disorders Increased Suicidal Thoughts	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Psychiatric disorders Insomnia	18.4% 18/98 • Number of events 19 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	14.9% 14/94 • Number of events 14 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Psychiatric disorders Irritability	7.1% 7/98 • Number of events 8 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	5.3% 5/94 • Number of events 5 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Psychiatric disorders Mood Swings	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	2.1% 2/94 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Psychiatric disorders Nightmares	6.1% 6/98 • Number of events 7 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	4.3% 4/94 • Number of events 4 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Psychiatric disorders Panic Episode	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Psychiatric disorders Vivid Dreams	3.1% 3/98 • Number of events 3 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	3.2% 3/94 • Number of events 3 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Renal and urinary disorders Nocturia	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Renal and urinary disorders Urinary Tract Infection	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	2.1% 2/94 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Reproductive system and breast disorders Dysmenorrhea	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Reproductive system and breast disorders Heavy Menstrual Bleeding	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Reproductive system and breast disorders Polycystic Ovaries	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Reproductive system and breast disorders Vulva Cyst	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Respiratory, thoracic and mediastinal disorders Cough	7.1% 7/98 • Number of events 9 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	2.1% 2/94 • Number of events 3 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Respiratory, thoracic and mediastinal disorders Dysphonia	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	4.1% 4/98 • Number of events 4 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	2.1% 2/94 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Respiratory, thoracic and mediastinal disorders Pharyngitis	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Respiratory, thoracic and mediastinal disorders Sinus Congestion	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Respiratory, thoracic and mediastinal disorders Sore Throat	3.1% 3/98 • Number of events 3 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	3.2% 3/94 • Number of events 3 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Respiratory, thoracic and mediastinal disorders Throat Irritation	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	2.1% 2/94 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Respiratory, thoracic and mediastinal disorders Viral Upper Respiratory Tract Infection	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Respiratory, thoracic and mediastinal disorders Wheezing	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Skin and subcutaneous tissue disorders Acne	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	2.1% 2/94 • Number of events 2 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Skin and subcutaneous tissue disorders Dermatitis Contact	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Skin and subcutaneous tissue disorders Night Sweats	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	2.1% 2/94 • Number of events 3 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Social circumstances Road Traffic Accident	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Surgical and medical procedures Dental Operation	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Surgical and medical procedures Intrauterine Contraception	1.0% 1/98 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	0.00% 0/94 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Surgical and medical procedures Skin Lesion Removal	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.
Vascular disorders Hot Flashes	0.00% 0/98 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.	1.1% 1/94 • Number of events 1 • Adverse event data were collected throughout the full 6-month participant enrollment period (includes 12 weeks of study treatment and extended post-treatment follow-up thereafter) Adverse events were assessed by the medical clinician during participant interviews and coded via MedDRA terminology.

Additional Information

Kevin M. Gray, M.D.

Medical University of South Carolina

Phone: 843-792-6330

Email: graykm@musc.edu

Results disclosure agreements

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