Trial Outcomes & Findings for Vitamin D Oral Replacement in Asthma (NCT NCT03686150)

Last Updated: 2023-04-19

Results Overview

Determine the best vitamin D supplementation level based on PK analysis of participants enrolled in Part 1. The PK of 25(OH)D after vitamin D supplementation in children will be characterized using a 2-compartment population PK model (popPK) with linear absorption and elimination kinetics.

Recruitment status

COMPLETED

Study phase

Target enrollment

112 participants

Primary outcome timeframe

20 weeks

Results posted on

2023-04-19

Participant Flow

A total of 166 study participants consented to be screened for the trial; 112 met eligibility criteria and were randomized onto the trial. The trial comprised of a Dose Finding part (Part 1) and a Dose Confirming par (Part 2). During Part 1, participants (children) were enrolled and randomized to one of four dose groups at 1:1:1:1 allocation ratio. During Part 2, participants (children) were randomized to one of two dose groups at 2:1 allocation ratio.

Participant milestones

Participant milestones
Measure	Part 1, Cohort 1 Vitamin D3 Oral Regimen Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 1, Cohort 2 Vitamin D3 Oral Regimen Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 1, Cohort 3 Vitamin D3 Oral Regimen Vitamin D: 6000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 1, Cohort 4 Vitamin D3 Oral Regimen Vitamin D: 600 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 2, Cohort A Vitamin D3 Oral Regimen Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 2, Cohort B Vitamin D Oral Regimen Vitamin D: 600 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
Overall Study STARTED	13	12	11	12	43	21
Overall Study COMPLETED	11	10	10	12	42	18
Overall Study NOT COMPLETED	2	2	1	0	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1, Cohort 1 Vitamin D3 Oral Regimen Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 1, Cohort 2 Vitamin D3 Oral Regimen Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 1, Cohort 3 Vitamin D3 Oral Regimen Vitamin D: 6000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 2, Cohort A Vitamin D3 Oral Regimen Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 2, Cohort B Vitamin D Oral Regimen Vitamin D: 600 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
Overall Study Withdrawal by Subject	1	1	1	1	2
Overall Study Physician Decision	1	0	0	0	1
Overall Study Lost to Follow-up	0	1	0	0	0

Baseline Characteristics

Note: Cohort 1, Cohort A, and Cohort B each one participant with missing 25(OH)D measurement at baseline.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1, Cohort 1 Vitamin D3 Oral Regimen n=13 Participants Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 1, Cohort 2 Vitamin D3 Oral Regimen n=12 Participants Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 1, Cohort 3 Vitamin D3 Oral Regimen n=11 Participants Vitamin D: 6000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 1, Cohort 4 Vitamin D3 Oral Regimen n=12 Participants Vitamin D: 600 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 2, Cohort A Vitamin D3 Oral Regimen n=43 Participants Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 2, Cohort B Vitamin D Oral Regimen n=21 Participants Vitamin D: 600 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Total n=112 Participants Total of all reporting groups
Rural-Urban Commuting Area (RUCA) codes Rural	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=11 Participants	0 Participants n=12 Participants	3 Participants n=43 Participants	1 Participants n=21 Participants	4 Participants n=112 Participants
Age, Continuous	12.8 years STANDARD_DEVIATION 3.1 • n=13 Participants	12.3 years STANDARD_DEVIATION 3.4 • n=12 Participants	11.5 years STANDARD_DEVIATION 3.6 • n=11 Participants	12.5 years STANDARD_DEVIATION 2.9 • n=12 Participants	12.2 years STANDARD_DEVIATION 2.5 • n=43 Participants	11.7 years STANDARD_DEVIATION 2.6 • n=21 Participants	12.1 years STANDARD_DEVIATION 2.8 • n=112 Participants
Sex: Female, Male Female	6 Participants n=13 Participants	7 Participants n=12 Participants	5 Participants n=11 Participants	5 Participants n=12 Participants	20 Participants n=43 Participants	10 Participants n=21 Participants	53 Participants n=112 Participants
Sex: Female, Male Male	7 Participants n=13 Participants	5 Participants n=12 Participants	6 Participants n=11 Participants	7 Participants n=12 Participants	23 Participants n=43 Participants	11 Participants n=21 Participants	59 Participants n=112 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=13 Participants	2 Participants n=12 Participants	2 Participants n=11 Participants	1 Participants n=12 Participants	7 Participants n=43 Participants	3 Participants n=21 Participants	20 Participants n=112 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=13 Participants	10 Participants n=12 Participants	8 Participants n=11 Participants	10 Participants n=12 Participants	33 Participants n=43 Participants	18 Participants n=21 Participants	86 Participants n=112 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=13 Participants	0 Participants n=12 Participants	1 Participants n=11 Participants	1 Participants n=12 Participants	3 Participants n=43 Participants	0 Participants n=21 Participants	6 Participants n=112 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=11 Participants	0 Participants n=12 Participants	3 Participants n=43 Participants	1 Participants n=21 Participants	4 Participants n=112 Participants
Race (NIH/OMB) Asian	0 Participants n=13 Participants	1 Participants n=12 Participants	1 Participants n=11 Participants	0 Participants n=12 Participants	0 Participants n=43 Participants	0 Participants n=21 Participants	2 Participants n=112 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=11 Participants	0 Participants n=12 Participants	1 Participants n=43 Participants	0 Participants n=21 Participants	1 Participants n=112 Participants
Race (NIH/OMB) Black or African American	6 Participants n=13 Participants	4 Participants n=12 Participants	5 Participants n=11 Participants	6 Participants n=12 Participants	15 Participants n=43 Participants	9 Participants n=21 Participants	45 Participants n=112 Participants
Race (NIH/OMB) White	4 Participants n=13 Participants	5 Participants n=12 Participants	3 Participants n=11 Participants	5 Participants n=12 Participants	19 Participants n=43 Participants	10 Participants n=21 Participants	46 Participants n=112 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants	1 Participants n=12 Participants	1 Participants n=11 Participants	1 Participants n=12 Participants	2 Participants n=43 Participants	1 Participants n=21 Participants	6 Participants n=112 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=13 Participants	1 Participants n=12 Participants	1 Participants n=11 Participants	0 Participants n=12 Participants	3 Participants n=43 Participants	0 Participants n=21 Participants	8 Participants n=112 Participants
Baseline Body Mass Index (BMI)	33.9 kg/m^2 STANDARD_DEVIATION 8.4 • n=13 Participants	29.7 kg/m^2 STANDARD_DEVIATION 6.4 • n=12 Participants	30.1 kg/m^2 STANDARD_DEVIATION 4.3 • n=11 Participants	32.2 kg/m^2 STANDARD_DEVIATION 9.2 • n=12 Participants	30.8 kg/m^2 STANDARD_DEVIATION 6.9 • n=43 Participants	30.3 kg/m^2 STANDARD_DEVIATION 8.2 • n=21 Participants	31.0 kg/m^2 STANDARD_DEVIATION 7.3 • n=112 Participants
BMI percentile >= 85th to < 95th	3 Participants n=13 Participants	2 Participants n=12 Participants	2 Participants n=11 Participants	3 Participants n=12 Participants	9 Participants n=43 Participants	5 Participants n=21 Participants	24 Participants n=112 Participants
BMI percentile >= 95th to < 99th	4 Participants n=13 Participants	3 Participants n=12 Participants	2 Participants n=11 Participants	3 Participants n=12 Participants	16 Participants n=43 Participants	8 Participants n=21 Participants	36 Participants n=112 Participants
BMI percentile >= 99th	6 Participants n=13 Participants	7 Participants n=12 Participants	7 Participants n=11 Participants	6 Participants n=12 Participants	18 Participants n=43 Participants	8 Participants n=21 Participants	52 Participants n=112 Participants
Rural-Urban Commuting Area (RUCA) codes Metropolitan	13 Participants n=13 Participants	10 Participants n=12 Participants	9 Participants n=11 Participants	11 Participants n=12 Participants	32 Participants n=43 Participants	17 Participants n=21 Participants	92 Participants n=112 Participants
Rural-Urban Commuting Area (RUCA) codes Micropolitan	0 Participants n=13 Participants	1 Participants n=12 Participants	1 Participants n=11 Participants	0 Participants n=12 Participants	5 Participants n=43 Participants	1 Participants n=21 Participants	8 Participants n=112 Participants
Rural-Urban Commuting Area (RUCA) codes Small town	0 Participants n=13 Participants	1 Participants n=12 Participants	1 Participants n=11 Participants	1 Participants n=12 Participants	3 Participants n=43 Participants	2 Participants n=21 Participants	8 Participants n=112 Participants
Baseline 25(OH)D	18.3 ng/mL STANDARD_DEVIATION 6.5 • n=12 Participants • Note: Cohort 1, Cohort A, and Cohort B each one participant with missing 25(OH)D measurement at baseline.	20.8 ng/mL STANDARD_DEVIATION 7.2 • n=12 Participants • Note: Cohort 1, Cohort A, and Cohort B each one participant with missing 25(OH)D measurement at baseline.	19.0 ng/mL STANDARD_DEVIATION 5.2 • n=11 Participants • Note: Cohort 1, Cohort A, and Cohort B each one participant with missing 25(OH)D measurement at baseline.	17.6 ng/mL STANDARD_DEVIATION 5.8 • n=12 Participants • Note: Cohort 1, Cohort A, and Cohort B each one participant with missing 25(OH)D measurement at baseline.	17.7 ng/mL STANDARD_DEVIATION 6.0 • n=42 Participants • Note: Cohort 1, Cohort A, and Cohort B each one participant with missing 25(OH)D measurement at baseline.	16.3 ng/mL STANDARD_DEVIATION 5.2 • n=20 Participants • Note: Cohort 1, Cohort A, and Cohort B each one participant with missing 25(OH)D measurement at baseline.	18.0 ng/mL STANDARD_DEVIATION 6.0 • n=109 Participants • Note: Cohort 1, Cohort A, and Cohort B each one participant with missing 25(OH)D measurement at baseline.
Baseline 25(OH)D level > 100 ng/mL Yes	0 Participants n=12 Participants • Note: Cohort 1, Cohort A, and Cohort B each had one participant with missing 25(OH) D values at baseline.	0 Participants n=12 Participants • Note: Cohort 1, Cohort A, and Cohort B each had one participant with missing 25(OH) D values at baseline.	0 Participants n=11 Participants • Note: Cohort 1, Cohort A, and Cohort B each had one participant with missing 25(OH) D values at baseline.	0 Participants n=12 Participants • Note: Cohort 1, Cohort A, and Cohort B each had one participant with missing 25(OH) D values at baseline.	0 Participants n=42 Participants • Note: Cohort 1, Cohort A, and Cohort B each had one participant with missing 25(OH) D values at baseline.	0 Participants n=20 Participants • Note: Cohort 1, Cohort A, and Cohort B each had one participant with missing 25(OH) D values at baseline.	0 Participants n=109 Participants • Note: Cohort 1, Cohort A, and Cohort B each had one participant with missing 25(OH) D values at baseline.
Baseline 25(OH)D level > 100 ng/mL No	12 Participants n=12 Participants • Note: Cohort 1, Cohort A, and Cohort B each had one participant with missing 25(OH) D values at baseline.	12 Participants n=12 Participants • Note: Cohort 1, Cohort A, and Cohort B each had one participant with missing 25(OH) D values at baseline.	11 Participants n=11 Participants • Note: Cohort 1, Cohort A, and Cohort B each had one participant with missing 25(OH) D values at baseline.	12 Participants n=12 Participants • Note: Cohort 1, Cohort A, and Cohort B each had one participant with missing 25(OH) D values at baseline.	42 Participants n=42 Participants • Note: Cohort 1, Cohort A, and Cohort B each had one participant with missing 25(OH) D values at baseline.	20 Participants n=20 Participants • Note: Cohort 1, Cohort A, and Cohort B each had one participant with missing 25(OH) D values at baseline.	109 Participants n=109 Participants • Note: Cohort 1, Cohort A, and Cohort B each had one participant with missing 25(OH) D values at baseline.

PRIMARY outcome

Timeframe: 20 weeks

Population: A total of 263 PK samples from 48 participants were collected in part 1 of the VDORA1 study. For the population PK analysis, 36 samples with missing prior dosing information from 13 participants were excluded, leaving a final analysis population of 44 participants with 227 serum concentrations.

Outcome measures

Outcome measures
Measure	Vitamin D3 Oral Regimen n=227 Serum Concentrations Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 2, Cohort B Vitamin D Oral Regimen Vitamin D: 600 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
Part 1: Optimal Dosing Level to Use in Part 2 Daily Dose (IU)	8000 IU	—
Part 1: Optimal Dosing Level to Use in Part 2 Single Loading Dose (IU)	50000 IU	—

PRIMARY outcome

Timeframe: 16 weeks

Population: One participant from Cohort A and three participants from Cohort B did not have 25(OH)D measurements at Visit 6 (week 16).

Proportion of participants in part 2 who achieve vitamin levels \>= 40 ng/ml

Outcome measures

Outcome measures
Measure	Vitamin D3 Oral Regimen n=42 Participants Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 2, Cohort B Vitamin D Oral Regimen n=18 Participants Vitamin D: 600 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml	0.786 proportion of participants Interval 0.641 to 0.883	0 proportion of participants Interval 0.0 to 0.176

Adverse Events

Part 1, Cohort 1 Vitamin D3 Oral Regimen

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Part 1, Cohort 2 Vitamin D3 Oral Regimen

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Part 1, Cohort 3 Vitamin D3 Oral Regimen

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Part 1, Cohort 4 Vitamin D3 Oral Regimen

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Part 2, Cohort A Vitamin D3 Oral Regimen

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Part 2, Cohort B Vitamin D Oral Regimen

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1, Cohort 1 Vitamin D3 Oral Regimen n=13 participants at risk Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 1, Cohort 2 Vitamin D3 Oral Regimen n=12 participants at risk Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 1, Cohort 3 Vitamin D3 Oral Regimen n=11 participants at risk Vitamin D: 6000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 1, Cohort 4 Vitamin D3 Oral Regimen n=12 participants at risk Vitamin D: 600 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 2, Cohort A Vitamin D3 Oral Regimen n=43 participants at risk Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 2, Cohort B Vitamin D Oral Regimen n=21 participants at risk Vitamin D: 600 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Immune system disorders Anaphylactic Reaction	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.

Other adverse events

Other adverse events
Measure	Part 1, Cohort 1 Vitamin D3 Oral Regimen n=13 participants at risk Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 1, Cohort 2 Vitamin D3 Oral Regimen n=12 participants at risk Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 1, Cohort 3 Vitamin D3 Oral Regimen n=11 participants at risk Vitamin D: 6000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 1, Cohort 4 Vitamin D3 Oral Regimen n=12 participants at risk Vitamin D: 600 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 2, Cohort A Vitamin D3 Oral Regimen n=43 participants at risk Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation	Part 2, Cohort B Vitamin D Oral Regimen n=21 participants at risk Vitamin D: 600 IU daily dose Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
Gastrointestinal disorders abdominal discomfort	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Gastrointestinal disorders abdominal pain upper	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Skin and subcutaneous tissue disorders acarodermatitis	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Skin and subcutaneous tissue disorders acne	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Surgical and medical procedures adenoidectomy	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Surgical and medical procedures adenotonsillectomy	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Skin and subcutaneous tissue disorders alopecia	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Infections and infestations amebiasis	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Immune system disorders anaphylactic reaction	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Injury, poisoning and procedural complications animal scratch	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Musculoskeletal and connective tissue disorders arthralgia	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Injury, poisoning and procedural complications arthropod bite	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
General disorders asthenia	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Immune system disorders asthma	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.5% 2/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders asthma	30.8% 4/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	25.0% 3/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	45.5% 5/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	25.0% 3/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	14.3% 3/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Surgical and medical procedures cardiac ablation	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Ear and labyrinth disorders cerumen impaction	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders chest cold	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
General disorders chest discomfort	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
General disorders chills	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Injury, poisoning and procedural complications concussion	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Eye disorders conjunctivitis	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Infections and infestations conjunctivitis	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Gastrointestinal disorders constipation	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Injury, poisoning and procedural complications contusion	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Infections and infestations coronavirus infection	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.5% 2/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders cough	30.8% 4/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	33.3% 4/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	45.5% 5/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	25.0% 3/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.7% 2/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.5% 2/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Psychiatric disorders depression	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Gastrointestinal disorders diarrhea	15.4% 2/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Nervous system disorders dizziness	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Reproductive system and breast disorders dysmenorrhoea	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders dyspnoea	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Infections and infestations ear infection	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	16.7% 2/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Injury, poisoning and procedural complications ear injury	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Skin and subcutaneous tissue disorders eczema	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Psychiatric disorders emotional disorder of childhood	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Gastrointestinal disorders eosinophilic oesophagitis	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders epistaxis	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Vascular disorders epixtaxis	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Eye disorders eye pain	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Eye disorders eyelid sensory disorder	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Injury, poisoning and procedural complications fall	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
General disorders fatigue	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Infections and infestations fungal skin infection	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Gastrointestinal disorders gastritis viral	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Gastrointestinal disorders gastroenteritis	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Gastrointestinal disorders gastroenteritis viral	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Gastrointestinal disorders gastrointestinal reflux disease	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Musculoskeletal and connective tissue disorders groin pain	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Nervous system disorders headache	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	25.0% 3/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	27.3% 3/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	16.7% 2/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	7.0% 3/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Skin and subcutaneous tissue disorders hidradenitis	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Immune system disorders hypersensitivity	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	14.3% 3/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Infections and infestations influenza	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Investigations influenza b virus test positive	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Nervous system disorders insomnia	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Blood and lymphatic system disorders iron deficiency anemia	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Injury, poisoning and procedural complications joint injury	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Injury, poisoning and procedural complications laceration	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders laryngitis	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Injury, poisoning and procedural complications ligament sprain	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders lower respiratory tract congestion	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Nervous system disorders migraine	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Injury, poisoning and procedural complications muscle strain	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Musculoskeletal and connective tissue disorders musculoskeletal discomfort	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Musculoskeletal and connective tissue disorders musculoskeletal pain	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Musculoskeletal and connective tissue disorders myalgia	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders nasal congestion	15.4% 2/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	36.4% 4/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Infections and infestations nasopharyngitis	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders nasopharyngitis	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.5% 2/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Gastrointestinal disorders nausea	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Eye disorders ocular discomfort	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
General disorders oedema peripheral	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Infections and infestations oral herpes	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Gastrointestinal disorders oropharyngeal pain	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	18.2% 2/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders oropharyngeal pain	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	16.7% 2/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
General disorders pain	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Musculoskeletal and connective tissue disorders pain in extremity	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders painful respiration	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Nervous system disorders paralysis	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Nervous system disorders paresthesia	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Infections and infestations paronychia	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
General disorders peripheral coldness	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders pharyngitis streptococcal	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders pneumonia	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Metabolism and nutrition disorders polydipsia	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
General disorders post procedural discomfort	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
General disorders procedural pain	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Injury, poisoning and procedural complications procedural vomiting	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
General disorders pyrexia	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	25.0% 3/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Skin and subcutaneous tissue disorders rash	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	16.7% 2/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	27.3% 3/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.7% 2/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders respiratory tract congestion	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders respiratory tract infection	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders respiratory tract infection viral	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Surgical and medical procedures scar excision	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders seasonal allergy	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Infections and infestations sinusitis	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders sinusitis	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders sneezing	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Gastrointestinal disorders stomatitis	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Injury, poisoning and procedural complications thermal burning	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Skin and subcutaneous tissue disorders tinea pedis	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Ear and labyrinth disorders tinnitus	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Surgical and medical procedures tonsillectomy	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Surgical and medical procedures tooth extraction	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Surgical and medical procedures turbinectomy	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Surgical and medical procedures turbinoplasty	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Infections and infestations upper respiratory infection	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders upper respiratory infection	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Infections and infestations upper respiratory tract infection	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	25.0% 3/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders upper respiratory tract infection	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Renal and urinary disorders urine abnormality	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Investigations urine calcium/creatinine ratio increased	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Vascular disorders vessel puncture site bruise	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Injury, poisoning and procedural complications vessel puncture site pain	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Infections and infestations viral infection	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders viral upper respiratory tract infection	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Gastrointestinal disorders vomiting	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	9.1% 1/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	16.7% 2/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Infections and infestations vulvovaginal mycotic infection	0.00% 0/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Respiratory, thoracic and mediastinal disorders wheezing	15.4% 2/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	18.2% 2/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	8.3% 1/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
Surgical and medical procedures wisdom teeth removal	7.7% 1/13 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/11 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	0.00% 0/12 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	2.3% 1/43 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.	4.8% 1/21 • Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period) Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.

Additional Information

Songthip Ounpraseuth

University of Arkansas for Medical Sciences

Phone: 501-686-7233

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place