Trial Outcomes & Findings for Varenicline for Adolescent Smoking Cessation (NCT NCT01509547)

NCT ID: NCT01509547

Last Updated: 2020-07-01

Results Overview

Self-reported 7-day cigarette abstinence, confirmed by urine corinne ≤50 ng/mL at the end-of-treatment (week 12) visit

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

157 participants

Primary outcome timeframe

7 days at end of treatment

Results posted on

2020-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	Varenicline Participants \>55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. Varenicline: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.	Placebo Participants \>55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. placebo: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.
Overall Study STARTED	77	80
Overall Study COMPLETED	42	41
Overall Study NOT COMPLETED	35	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Varenicline Participants \>55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. Varenicline: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.	Placebo Participants \>55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. placebo: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.
Overall Study Lost to Follow-up	24	14
Overall Study Withdrawal by Subject	11	24
Overall Study Physician Decision	0	1

Baseline Characteristics

Varenicline for Adolescent Smoking Cessation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Varenicline n=77 Participants Participants \>55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. Varenicline: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.	Placebo n=80 Participants Participants \>55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. placebo: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.	Total n=157 Participants Total of all reporting groups
Age, Continuous	19.1 years STANDARD_DEVIATION 1.5 • n=5 Participants	19.1 years STANDARD_DEVIATION 1.4 • n=7 Participants	19.1 years STANDARD_DEVIATION 1.5 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	35 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	45 Participants n=7 Participants	94 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=5 Participants	79 Participants n=7 Participants	153 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	54 Participants n=5 Participants	66 Participants n=7 Participants	120 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	77 participants n=5 Participants	80 participants n=7 Participants	157 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days at end of treatment

Population: Intent-to-treat population

Self-reported 7-day cigarette abstinence, confirmed by urine corinne ≤50 ng/mL at the end-of-treatment (week 12) visit

Outcome measures

Outcome measures
Measure	Varenicline n=77 Participants Participants \>55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. Varenicline: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.	Placebo n=80 Participants Participants \>55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. placebo: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.
Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment	4 Participants	4 Participants

PRIMARY outcome

Timeframe: 26 weeks (12 weeks of treatment plus full post-treatment follow-up)

Clinician-collected adverse events (regardless of relatedness to medication) occurring at any point after randomization and initiation of treatment.

Outcome measures

Outcome measures
Measure	Varenicline n=77 Participants Participants \>55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. Varenicline: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.	Placebo n=80 Participants Participants \>55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. placebo: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.
Number of Participants Experiencing Treatment-emergent Adverse Events	55 Participants	60 Participants

SECONDARY outcome

Timeframe: 12 weeks (all of active treatment)

Self-reported between-visit abstinence at weekly visits during treatment (reported as percentage of total possible visits across all participants at which participants self-reported abstinence). Missing data were imputed to non-abstinence.

Outcome measures

Outcome measures
Measure	Varenicline n=77 Participants Participants \>55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. Varenicline: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.	Placebo n=80 Participants Participants \>55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. placebo: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.
Percentage of Visits With Abstinence During Treatment	14.2 percentage of visits with abstinence Interval 11.9 to 16.4	7.3 percentage of visits with abstinence Interval 5.6 to 8.9

SECONDARY outcome

Timeframe: One week abstinence at the Week 16 and Week 26 post-treatment follow-up visits

Self-reported abstinence at post-treatment follow-up visits (reported as percentage of total possible post-treatment follow-up visits at which abstinence in the prior week was self-reported). Missing data were imputed to non-abstinence.

Outcome measures

Outcome measures
Measure	Varenicline n=77 Participants Participants \>55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. Varenicline: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.	Placebo n=80 Participants Participants \>55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. placebo: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.
Percentage of Post-treatment Visits With Abstinence	20.8 percentage of visits with abstinence Interval 14.4 to 27.2	10.6 percentage of visits with abstinence Interval 5.8 to 15.4

SECONDARY outcome

Timeframe: 12 weeks of active treatment

Number of participants achieving 7+ days of self-reported abstinence at any point during active treatment

Outcome measures

Outcome measures
Measure	Varenicline n=77 Participants Participants \>55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. Varenicline: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.	Placebo n=80 Participants Participants \>55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. placebo: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.
Number of Participants Achieving 7+ Days Abstinence at Any Point During Treatment	31 Participants	24 Participants

Adverse Events

Varenicline

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Kevin M. Gray, M.D.

Medical University of South Carolina

Phone: 843-792-6330

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Varenicline n=77 participants at risk Participants \>55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. Varenicline: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.	Placebo n=80 participants at risk Participants \>55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks. placebo: participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.
Ear and labyrinth disorders ear congestion	0.00% 0/77 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	1.2% 1/80 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Eye disorders blurred vision	1.3% 1/77 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	0.00% 0/80 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Eye disorders conjunctivitis	1.3% 1/77 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	0.00% 0/80 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Gastrointestinal disorders abdominal pain	0.00% 0/77 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	1.2% 1/80 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Gastrointestinal disorders constipation	1.3% 1/77 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	1.2% 1/80 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Gastrointestinal disorders diarrhoea	2.6% 2/77 • Number of events 2 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	1.2% 1/80 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Gastrointestinal disorders dry mouth	0.00% 0/77 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	2.5% 2/80 • Number of events 2 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Gastrointestinal disorders dyspepsia	1.3% 1/77 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	0.00% 0/80 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Gastrointestinal disorders dyspepsia (worsening)	2.6% 2/77 • Number of events 2 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	1.2% 1/80 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Gastrointestinal disorders flatulence	0.00% 0/77 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	1.2% 1/80 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Gastrointestinal disorders GERD	1.3% 1/77 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	0.00% 0/80 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Gastrointestinal disorders gastritis	1.3% 1/77 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	0.00% 0/80 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Gastrointestinal disorders gastroenteritis	1.3% 1/77 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	3.8% 3/80 • Number of events 3 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Gastrointestinal disorders nausea	31.2% 24/77 • Number of events 28 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	18.8% 15/80 • Number of events 15 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Gastrointestinal disorders salivary hypersecretion	0.00% 0/77 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	1.2% 1/80 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Gastrointestinal disorders stomachache	3.9% 3/77 • Number of events 3 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	0.00% 0/80 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Gastrointestinal disorders stomatitis	1.3% 1/77 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	0.00% 0/80 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Gastrointestinal disorders vomiting	14.3% 11/77 • Number of events 15 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	7.5% 6/80 • Number of events 7 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
General disorders fatigue	1.3% 1/77 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	3.8% 3/80 • Number of events 3 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
General disorders chest pain	1.3% 1/77 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	1.2% 1/80 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Infections and infestations boil	3.9% 3/77 • Number of events 5 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	0.00% 0/80 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Infections and infestations bronchitis	5.2% 4/77 • Number of events 4 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	2.5% 2/80 • Number of events 2 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Infections and infestations cellulitis	1.3% 1/77 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	1.2% 1/80 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Infections and infestations folliculitis	0.00% 0/77 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	1.2% 1/80 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Infections and infestations gastroenteritis	1.3% 1/77 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	2.5% 2/80 • Number of events 2 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Infections and infestations influenza	2.6% 2/77 • Number of events 2 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	0.00% 0/80 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Infections and infestations influenza like illness	1.3% 1/77 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	2.5% 2/80 • Number of events 2 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Infections and infestations laryngitis	0.00% 0/77 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	1.2% 1/80 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Infections and infestations lung infection	0.00% 0/77 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	1.2% 1/80 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Infections and infestations oral herpes	0.00% 0/77 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	1.2% 1/80 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Infections and infestations otitis media	0.00% 0/77 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	1.2% 1/80 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Infections and infestations pharyngitis	2.6% 2/77 • Number of events 2 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	5.0% 4/80 • Number of events 4 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Infections and infestations pneumonia	1.3% 1/77 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	0.00% 0/80 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Infections and infestations sinusitis	5.2% 4/77 • Number of events 4 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	1.2% 1/80 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Infections and infestations urinary tract infection	0.00% 0/77 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	1.2% 1/80 • Number of events 2 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Infections and infestations vaginal infection	0.00% 0/77 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	3.8% 3/80 • Number of events 3 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Infections and infestations viral upper respiratory tract infection	27.3% 21/77 • Number of events 25 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	16.2% 13/80 • Number of events 15 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Injury, poisoning and procedural complications contusion	1.3% 1/77 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	0.00% 0/80 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Injury, poisoning and procedural complications corneal abrasion	1.3% 1/77 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	0.00% 0/80 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.
Injury, poisoning and procedural complications fracture	0.00% 0/77 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.	1.2% 1/80 • Number of events 1 • 6 months (randomization to last post-treatment follow-up visit) Assessed and coded in MedDRA terminology by the medical clinician at each visit.