Trial Outcomes & Findings for Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis (NCT NCT02966834)

Last Updated: 2021-05-04

Results Overview

Participants were required to score the severity of their itching using a 0-10 numerical rating scale (NRS) where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the average of the scores in the 7 days prior to the Week 4 (Visit 3 \[V3\]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was done using Analysis of covariance (ANCOVA) including treatment group and centered Mean Worst Daily Itch score at Baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

147 participants

Primary outcome timeframe

Baseline and Week 16

Results posted on

2021-05-04

Participant Flow

This study was conducted across 66 centers in 10 countries. The 40 milligrams (mg) twice daily dose group was added and recruitment into the 20 mg twice daily dose group was discontinued following the pre-specified interim analysis.

A total of 147 adult participants were randomized in this study.

Participant milestones

Participant milestones
Measure	Placebo Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 180 mg QD Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Main Study Period (Up to 12 Weeks) STARTED	36	16	23	27	23	22
Main Study Period (Up to 12 Weeks) COMPLETED	35	16	19	19	22	17
Main Study Period (Up to 12 Weeks) NOT COMPLETED	1	0	4	8	1	5
Final Study Period (Up to 4 Weeks) STARTED	35	16	19	19	21	17
Final Study Period (Up to 4 Weeks) COMPLETED	35	16	19	19	21	17
Final Study Period (Up to 4 Weeks) NOT COMPLETED	0	0	0	0	0	0
Follow-up (Up to 4 Weeks) STARTED	35	16	23	27	22	22
Follow-up (Up to 4 Weeks) COMPLETED	35	16	22	22	22	21
Follow-up (Up to 4 Weeks) NOT COMPLETED	0	0	1	5	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 90 mg QD Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 180 mg QD Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Main Study Period (Up to 12 Weeks) Adverse Event	0	0	0	1	0
Main Study Period (Up to 12 Weeks) Lack of Efficacy	1	0	0	0	0
Main Study Period (Up to 12 Weeks) Discontinued study treatment and entered follow-up	0	4	8	0	5
Follow-up (Up to 4 Weeks) Adverse Event	0	1	2	0	1
Follow-up (Up to 4 Weeks) Withdrawal by Subject	0	0	2	0	0
Follow-up (Up to 4 Weeks) Protocol Violation	0	0	1	0	0

Baseline Characteristics

Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=36 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=23 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 180 mg QD n=27 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=23 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.	Total n=147 Participants Total of all reporting groups
Age, Continuous	54.4 Years STANDARD_DEVIATION 11.06 • n=5 Participants	58.5 Years STANDARD_DEVIATION 7.35 • n=7 Participants	52.5 Years STANDARD_DEVIATION 12.32 • n=5 Participants	58.9 Years STANDARD_DEVIATION 11.10 • n=4 Participants	55.6 Years STANDARD_DEVIATION 11.23 • n=21 Participants	56.2 Years STANDARD_DEVIATION 11.32 • n=10 Participants	55.8 Years STANDARD_DEVIATION 11.04 • n=115 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	16 Participants n=7 Participants	21 Participants n=5 Participants	25 Participants n=4 Participants	22 Participants n=21 Participants	20 Participants n=10 Participants	138 Participants n=115 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	9 Participants n=115 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	8 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	4 Participants n=21 Participants	7 Participants n=10 Participants	38 Participants n=115 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	26 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants	19 Participants n=4 Participants	16 Participants n=21 Participants	15 Participants n=10 Participants	103 Participants n=115 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	4 Participants n=115 Participants

PRIMARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-Treat (ITT) Population comprised of all randomized participants who received at least one dose of study treatment, had a Baseline and at least one on-treatment assessment. Only those participants with data available at the specified data points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=20 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=22 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=21 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score	-1.73 Scores on a scale Interval -2.44 to -1.01	-2.19 Scores on a scale Interval -3.26 to -1.12	-2.60 Scores on a scale Interval -3.55 to -1.65	-2.60 Scores on a scale Interval -3.51 to -1.7	-2.86 Scores on a scale Interval -3.76 to -1.95	-2.25 Scores on a scale Interval -3.19 to -1.32

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: ITT Population. Only those participants with data available at the specified data points were analyzed.

PBC-40 is a disease-specific health-related quality of life (HRQoL) questionnaire for use in PBC participants. It consists of 40 questions arranged in 6 domains with 3 to 11 questions in each domain. Each question is scored from 1 (least impact) to 5 (greatest impact). All questions within a domain are summed to obtain individual domain score. Domains were: Symptoms (7 questions) with score range 7-35, Itch (3 questions) with score range 3-15, Fatigue (11 questions) with score range 11-55, Cognitive (6 questions) with score range 6-30, Emotional (3 questions) with score range 3-15, and Social (10 questions) with score range 10-50. Higher scores for individual domains represent a poor quality of life. Baseline is the assessment performed at Week 4 (V3) which is conducted prior to first dosing of randomized medication that evening. Change from Baseline was calculated as post-Baseline value minus Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=21 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=22 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=20 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale Symptoms	0.2 Scores on a scale Interval -1.0 to 1.4	0.4 Scores on a scale Interval -1.3 to 2.2	0.7 Scores on a scale Interval -0.8 to 2.3	-0.9 Scores on a scale Interval -2.4 to 0.6	0.3 Scores on a scale Interval -1.2 to 1.8	0.2 Scores on a scale Interval -1.4 to 1.8
Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale Cognitive	-0.3 Scores on a scale Interval -1.7 to 1.1	-0.3 Scores on a scale Interval -2.4 to 1.8	-0.9 Scores on a scale Interval -2.7 to 0.9	-0.1 Scores on a scale Interval -1.9 to 1.6	0.1 Scores on a scale Interval -1.6 to 1.9	-0.1 Scores on a scale Interval -2.0 to 1.7
Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale Itch	-2.3 Scores on a scale Interval -3.3 to -1.4	-1.9 Scores on a scale Interval -3.3 to -0.4	-2.6 Scores on a scale Interval -3.9 to -1.3	-2.7 Scores on a scale Interval -3.9 to -1.4	-3.4 Scores on a scale Interval -4.6 to -2.1	-2.7 Scores on a scale Interval -4.0 to -1.4
Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale Fatigue	-1.8 Scores on a scale Interval -4.0 to 0.4	-2.4 Scores on a scale Interval -5.6 to 0.7	-1.1 Scores on a scale Interval -3.8 to 1.7	1.7 Scores on a scale Interval -1.0 to 4.5	-0.1 Scores on a scale Interval -2.8 to 2.6	-1.8 Scores on a scale Interval -4.6 to 1.1
Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale Emotional	-0.5 Scores on a scale Interval -1.2 to 0.1	-1.4 Scores on a scale Interval -2.4 to -0.4	-0.4 Scores on a scale Interval -1.3 to 0.5	-0.6 Scores on a scale Interval -1.5 to 0.3	-1.4 Scores on a scale Interval -2.2 to -0.5	-0.6 Scores on a scale Interval -1.5 to 0.3
Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale Social	-0.8 Scores on a scale Interval -2.3 to 0.8	-0.5 Scores on a scale Interval -2.7 to 1.8	0.4 Scores on a scale Interval -1.5 to 2.4	-0.6 Scores on a scale Interval -2.5 to 1.3	-3.1 Scores on a scale Interval -5.1 to -1.2	-1.0 Scores on a scale Interval -3.0 to 1.0

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: High Risk Population comprised of subset of the ITT population who were assigned to the High Risk stratum for randomization (based upon serum ALP concentrations \>=1.67 times ULN and/or total bilirubin concentrations \>ULN at Day 1 (Visit 2). Only those participants with data available at the specified data points were analyzed.

Criteria for high risk of PBC progression is defined as serum ALP concentrations more than or equal to (\>=)1.67 times upper limit of normal (ULN) range and/or total bilirubin concentrations more than (\>)ULN at Day 1. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 (Day 1) or Visit 1 (Screening), excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=5 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=11 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=7 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=6 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=5 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Mean Change From Baseline at Week 16 in Serum Alkaline Phosphatase (ALP) Concentrations, in Participants With High Risk of PBC Progression	49.1 International units per Liter Interval -29.3 to 127.6	-57.7 International units per Liter Interval -179.6 to 64.3	-38.2 International units per Liter Interval -117.0 to 40.5	49.6 International units per Liter Interval -49.1 to 148.2	-29.2 International units per Liter Interval -136.7 to 78.3	19.1 International units per Liter Interval -97.7 to 136.0

SECONDARY outcome

Timeframe: At Week 16

Population: Restricted High Risk Population comprised of a subset of the High Risk population, i.e. all those participants assigned to the High Risk stratum for randomization who met the ALP/bilirubin criteria at both Visit 2 (Day 1) and Visit 3 (Week 4).

Number of participants with ALP \< 1.67 times ULN and total bilirubin \<= ULN at Week 16 is presented. The endpoint was analyzed in Restricted High Risk Population.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=5 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=9 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=9 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=6 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=7 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Number of Participants With Serum ALP Concentrations Less Than (<)1.67 Times ULN and Total Bilirubin Concentrations Less Than or Equal to (<=) ULN at Week 16	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: High Risk Population. Only those participants with data available at the specified data points were analyzed.

Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including Treatment group and Baseline.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=5 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=11 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=7 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=6 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=5 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Mean Change From Baseline at Week 16 in Serum Alanine Aminotransferase (ALT) Among Those With a High Risk of PBC Progression	13.0 International Units per Liter Interval -7.9 to 33.9	-8.4 International Units per Liter Interval -39.5 to 22.7	0.3 International Units per Liter Interval -20.7 to 21.2	-2.0 International Units per Liter Interval -29.0 to 25.1	-13.5 International Units per Liter Interval -42.8 to 15.9	13.2 International Units per Liter Interval -17.4 to 43.7

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: High Risk Population. Only those participants with data available at the specified data points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=5 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=11 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=7 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=6 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=5 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Mean Change From Baseline at Week 16 in Serum Aspartate Aminotransferase (AST) Among Those With a High Risk of PBC Progression	13.96 International Units per Liter Interval -4.55 to 32.46	-6.04 International Units per Liter Interval -34.2 to 22.12	-10.75 International Units per Liter Interval -28.9 to 7.4	-8.66 International Units per Liter Interval -32.24 to 14.93	-17.72 International Units per Liter Interval -42.77 to 7.34	8.16 International Units per Liter Interval -18.72 to 35.04

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: High Risk Population. Only those participants with data available at the specified data points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=5 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=11 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=7 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=6 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=5 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Mean Change From Baseline at Week 16 in Serum Gamma Glutamyl Transferase (GGT), Among Those With a High Risk of PBC Progression	47.5 International Units per Liter Interval -9.9 to 104.8	-58.5 International Units per Liter Interval -142.5 to 25.5	-18.0 International Units per Liter Interval -74.9 to 38.9	4.6 International Units per Liter Interval -66.5 to 75.8	-18.4 International Units per Liter Interval -93.6 to 56.8	-6.7 International Units per Liter Interval -89.1 to 75.8

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: High Risk Population. Only those participants with data available at the specified data points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=5 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=11 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=7 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=6 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=5 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Mean Change From Baseline at Week 16 in Total Bilirubin Concentration, Among Those With a High Risk of PBC Progression	1.258 Micromoles per Liter Interval -2.068 to 4.583	-4.841 Micromoles per Liter Interval -9.693 to 0.011	-1.079 Micromoles per Liter Interval -4.345 to 2.187	-0.975 Micromoles per Liter Interval -5.15 to 3.201	-0.234 Micromoles per Liter Interval -4.914 to 4.446	6.494 Micromoles per Liter Interval 1.622 to 11.365

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: High Risk Population. Only those participants with data available at the specified data points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=5 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=11 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=7 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=6 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=5 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Mean Change From Baseline at Week 16 in Albumin Concentration, Among Those With a High Risk of PBC Progression	0.0 Grams per Liter Interval -1.2 to 1.3	-0.5 Grams per Liter Interval -2.3 to 1.3	0.3 Grams per Liter Interval -1.0 to 1.6	0.8 Grams per Liter Interval -0.8 to 2.3	0.0 Grams per Liter Interval -1.7 to 1.7	0.7 Grams per Liter Interval -1.1 to 2.5

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: High Risk Population. Only those participants with data available at the specified data points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=5 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=11 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=6 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=7 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=5 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Mean Change From Baseline at Week 16 in Prothrombin International Normalized Ratio (INR), Among Those With a High Risk of PBC Progression	0.01 Ratio Interval -0.03 to 0.05	-0.01 Ratio Interval -0.06 to 0.04	-0.03 Ratio Interval -0.06 to 0.0	0.01 Ratio Interval -0.04 to 0.05	-0.02 Ratio Interval -0.07 to 0.02	-0.03 Ratio Interval -0.08 to 0.02

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: High Risk Population. Only those participants with data available at the specified data points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=5 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=11 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=6 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=7 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=5 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Mean Change From Baseline at Week 16 in Prothrombin Time, Among Those With a High Risk of PBC Progression	-0.10 Seconds Interval -0.4 to 0.2	0.05 Seconds Interval -0.33 to 0.44	-0.21 Seconds Interval -0.47 to 0.05	0.02 Seconds Interval -0.33 to 0.37	-0.18 Seconds Interval -0.51 to 0.15	-0.17 Seconds Interval -0.55 to 0.22

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Safety Population. It consisted of all randomized participants who received at least 1 dose of study intervention.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=23 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=27 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=23 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period Any non-SAE	17 Participants	11 Participants	19 Participants	24 Participants	16 Participants	18 Participants
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period Any SAE	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 4 weeks

Population: Safety Population

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=19 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=19 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=21 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=17 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Number of Participants With Non-SAEs and SAEs -Final Study Period Any non-SAE	2 Participants	6 Participants	8 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Non-SAEs and SAEs -Final Study Period Any SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 4 weeks

Population: Safety Population

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=23 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=27 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Number of Participants With Non-SAEs and SAEs - Follow-up Period Any SAE	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Non-SAEs and SAEs - Follow-up Period Any non-SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Weeks 8, 12, 16 and 20

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected to measure analyze the following parameters: albumin, calcium, Glomerular filtration rate (GFR) from creatinine, glucose, potassium and sodium. Participants were counted in the worst case category that their value changes to (low, within range \[w/in\] or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (for example \[e.g.\], high to high), or whose value became within range, were recorded in the "To w/in Range or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100 percent (%). Only "To Low" and/or "To High" categories with potential clinical importance data have been presented.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=23 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=27 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=23 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Albumin, To Low, Week 8, n=36, 16, 21, 21, 22, 19	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Albumin, To Low, Week 12, n=35, 16, 21, 23, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Albumin, To Low, Week 16, n=35, 16, 21, 22, 21, 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Albumin, To Low, Week 20, n=35, 16, 22, 22, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Calcium, To Low, Week 8, n=36, 16, 21, 21, 22, 19	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Calcium, To High, Week 8, n=36, 16, 21, 21, 22, 19	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Calcium, To Low, Week 12, n=35, 16, 21, 23, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Calcium, To High, Week 12, n=35, 16, 21, 23, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Calcium, To Low, Week 16, n=35, 16, 21, 22, 21, 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Calcium, To High, Week 16, n=35, 16, 21, 22, 21, 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Calcium, To Low, Week 20, n=35, 16, 22, 22, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Calcium, To High, Week 20, n=35, 16, 22, 22, 22, 21	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance GFR, To Low, Week 8, n=36, 16, 21, 21, 22, 19	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance GFR, To Low, Week 12, n=35, 15, 21, 23, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance GFR, To Low, Week 16, n=35, 16, 21, 22, 21, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance GFR, To Low, Week 20, n=35, 16, 22, 22, 22, 21	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Glucose ,To Low, Week 8, n=36, 16, 21, 21, 22, 19	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Glucose ,To High, Week 8, n=36, 16, 21, 21, 22, 19	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Glucose ,To Low, Week 12, n=35, 16, 21, 23, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Glucose, To High, Week 12, n=35, 16, 21, 23, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Glucose ,To Low, Week 16, n=35, 16, 21, 22, 21,20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Glucose, To High, Week 16, n=35, 16, 21, 22, 21, 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Glucose ,To Low, Week 20, n=35, 16, 22, 22, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Glucose, To High, Week 20, n=35, 16, 22, 22, 22, 21	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Potassium,To Low, Week 8, n=36, 16, 21, 21, 22, 19	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Potassium, To High, Week 8, n=36, 16, 21, 21, 22, 19	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Potassium,To Low, Week 12, n=35, 16, 21, 23, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Potassium, To High, Week 12, n=35, 16, 21, 23, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Potassium,To Low, Week 16, n=35, 16, 21, 22, 21, 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Potassium, To High, Week 16, n=35, 16, 21, 22, 21, 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Potassium,To Low, Week 20, n=35, 16, 22, 22, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Potassium, To High, Week 20, n=35, 16, 22,22, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Sodium, To Low, Week 8, n=36, 16, 21, 21, 22, 19	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Sodium, To High, Week 8, n=36, 16, 21, 21, 22, 19	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Sodium, To Low, Week 12, n=35, 16, 21, 23, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Sodium, To High, Week 12, n=35, 16, 21, 23, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Sodium, To Low, Week 16, n=35, 16, 21, 22, 21, 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Sodium, To High, Week 16, n=35, 16, 21, 22, 21, 20	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Sodium, To Low, Week 20, n=35, 16, 22, 22, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance Sodium, To High, Week 20, n=35, 16, 22, 22, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Weeks 8, 12, 16 and 20

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected to analyze the following parameters: hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. Participants were counted in the worst case category that their value changes to (low, w/in or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., high to high), or whose value became within range, were recorded in the "To w/in Range or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%. Only "To Low" and/or "To High" categories with potential clinical importance data have been presented.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=23 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=27 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=23 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Number of Participants With Hematology Data of Potential Clinical Importance Platelets,To High, Week 20, n=33, 16, 21, 21, 22, 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Leukocytes,To High, Week 16, n=34, 15, 21, 22, 20, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Leukocytes, To Low, Week 20, n=34,16, 22, 21, 22, 19	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Leukocytes, To High, Week 20, n=34,16, 22, 21, 22, 19	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Lymphocytes, To Low, Week 8, n=35,15, 21, 21, 22, 19	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Lymphocytes, To Low, Week 12, n=32,15,21,23, 22, 20	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Lymphocytes, To Low, Week 16, n=34, 15, 21, 22, 20, 21	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Lymphocytes, To Low, Week 20, n=34,16, 22, 21, 22, 19	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Neutrophils, To Low, Week 8,n=35,15, 21, 21, 22, 19	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Neutrophils, To Low, Week 12, n=32, 15, 21, 23, 22, 20	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Neutrophils, To Low, Week 16, n=34, 15, 21, 22, 20, 21	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Neutrophils, To Low, Week 20, n=34,16, 22, 21, 22,19	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Platelets, To Low, Week 8,n=36,15, 20, 21, 22,19	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Platelets, To High, Week 8,n=36,15, 20, 21, 22, 19	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Platelets, To Low, Week 12, n=33,14,19, 23, 22, 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Platelets,To High, Week 12, n=33, 14, 19, 23, 22, 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Platelets, To Low, Week 16, n=35, 14, 19, 22, 21, 21	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Platelets,To High, Week 16, n=35, 14, 19, 22, 21, 21	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Platelets, To Low, Week 20, n=33,16, 21, 21, 22, 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hematocrit, To High, Week 8,n=36, 16, 21, 21, 22, 19	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hematocrit, To High, Week 12, n=33, 15, 21, 23, 22, 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hematocrit, To High, Week 16, n=35, 15, 21, 22, 21, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hematocrit, To High, Week 20, n=34, 16, 22, 22, 22, 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hemoglobin, To High, Week 8,n=36,16, 21, 21, 22,19	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hemoglobin, To High, Week 12, n=33,15, 21, 23, 22, 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hemoglobin, To High, Week 16, n=35, 15, 21, 22, 21, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Hemoglobin, To High, Week 20, n=34,16, 22, 22, 22, 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Leukocytes, To Low, Week 8, n=36,15, 21, 21, 22,19	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Leukocytes,To High, Week 8, n=36,15, 21, 21, 22,19	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Leukocytes, To Low, Week 12, n=33,15, 21, 23, 22, 20	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Leukocytes,To High, Week 12, n=33,15,21,23, 22, 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data of Potential Clinical Importance Leukocytes, To Low, Week 16, n=34, 15, 21, 22, 20, 21	1 Participants	0 Participants	3 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At Weeks 8, 12, 16 and 20

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

A 12-lead ECG was recorded with the participant in a semi-supine position. 12-lead ECGs were obtained by using an automated ECG machine. Data for abnormal, not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=23 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=27 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=23 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters Abnormal, NCS, Week 8, n=36, 16, 21, 21, 22,19	10 Participants	2 Participants	1 Participants	7 Participants	8 Participants	4 Participants
Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters Abnormal, CS, Week 8, n=36, 16, 21, 21, 22, 19	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters Abnormal, NCS, Week 12, n= 35, 16, 20, 23, 22, 21	9 Participants	3 Participants	3 Participants	8 Participants	8 Participants	4 Participants
Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters Abnormal, CS, Week 12, n=35, 16, 20, 23, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters Abnormal, NCS, Week 16, n= 35, 16, 21, 21, 22 ,21	9 Participants	3 Participants	2 Participants	5 Participants	7 Participants	4 Participants
Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters Abnormal, CS, Week 16, n=35, 16, 21, 21, 22, 21	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters Abnormal, NCS, Week 20, n=35, 16, 22, 22, 22, 20	8 Participants	3 Participants	2 Participants	7 Participants	8 Participants	3 Participants
Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters Abnormal, CS, Week 20, n=35, 16, 22, 22, 22, 20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Week 20

Population: Safety Population. Only those participants with data available at the specified data points were analyzed .

SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=22 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=21 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP	-3.3 Millimeters of mercury (mmHg) Standard Deviation 13.33	-2.1 Millimeters of mercury (mmHg) Standard Deviation 11.47	0.1 Millimeters of mercury (mmHg) Standard Deviation 12.78	0.7 Millimeters of mercury (mmHg) Standard Deviation 10.42	-0.3 Millimeters of mercury (mmHg) Standard Deviation 15.16	2.0 Millimeters of mercury (mmHg) Standard Deviation 15.43
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP	-1.3 Millimeters of mercury (mmHg) Standard Deviation 8.99	0.3 Millimeters of mercury (mmHg) Standard Deviation 7.75	-0.3 Millimeters of mercury (mmHg) Standard Deviation 9.16	-0.7 Millimeters of mercury (mmHg) Standard Deviation 5.51	2.5 Millimeters of mercury (mmHg) Standard Deviation 8.64	2.3 Millimeters of mercury (mmHg) Standard Deviation 7.23

SECONDARY outcome

Timeframe: Baseline and Week 20

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Pulse rate was measured in a semi-supine position after 5 minutes of rest. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=22 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=21 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Change From Baseline in Pulse Rate	1.5 Beats per minute Standard Deviation 7.19	-2.6 Beats per minute Standard Deviation 10.35	1.2 Beats per minute Standard Deviation 10.91	-0.2 Beats per minute Standard Deviation 7.93	3.4 Beats per minute Standard Deviation 8.92	0.5 Beats per minute Standard Deviation 8.03

SECONDARY outcome

Timeframe: Baseline and Week 20

Population: Safety Population. Only those participants with data available at the specified data points were analyzed .

GSRS is a validated scale used to assess gastrointestinal symptoms experienced by participants over the preceding 5 to 7 days. GSRS was measured for all 5 domains: Average Diarrhea Syndrome Score, Average Indigestion Syndrome Score, Average Constipation Syndrome Score, Average Abdominal Pain Syndrome Score, Average Reflux Syndrome Score. All individual domains are scored on a 7-point Likert scale ranging from 1(not at all) to 7(extremely). Higher score indicate more severe symptoms. The Average Total GSRS score was mean of these 5 domains and ranges from 1 to 7. Higher score indicates worst possible degree of symptoms. The responses summarized at each visit are those given during the week prior to the visit, with exception of Day 1. Baseline is the most recent assessment completed by participant prior to randomization. Change from Baseline was calculated as post-Baseline value minus the Baseline value. Data has been presented for each domain along with the average Total GSRS score.

Outcome measures

Outcome measures
Measure	Placebo n=33 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=20 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=21 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=20 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment Average Diarrhea Syndrome Score	0.22 Scores on a scale Standard Deviation 1.343	0.15 Scores on a scale Standard Deviation 1.587	0.23 Scores on a scale Standard Deviation 1.180	-0.13 Scores on a scale Standard Deviation 0.637	-0.23 Scores on a scale Standard Deviation 1.729	0.22 Scores on a scale Standard Deviation 1.565
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment Average Indigestion Syndrome Score	-0.01 Scores on a scale Standard Deviation 1.138	0.09 Scores on a scale Standard Deviation 0.865	-0.03 Scores on a scale Standard Deviation 0.811	-0.14 Scores on a scale Standard Deviation 0.820	-0.31 Scores on a scale Standard Deviation 1.046	-0.54 Scores on a scale Standard Deviation 1.007
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment Average Constipation Syndrome Score	-0.03 Scores on a scale Standard Deviation 1.045	-0.15 Scores on a scale Standard Deviation 0.989	0.32 Scores on a scale Standard Deviation 1.370	-0.02 Scores on a scale Standard Deviation 0.934	-0.32 Scores on a scale Standard Deviation 1.215	-0.37 Scores on a scale Standard Deviation 0.772
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment Average Abdominal Pain Syndrome Score	-0.05 Scores on a scale Standard Deviation 1.074	0.06 Scores on a scale Standard Deviation 0.712	-0.02 Scores on a scale Standard Deviation 1.000	-0.06 Scores on a scale Standard Deviation 0.629	-0.08 Scores on a scale Standard Deviation 0.885	-0.25 Scores on a scale Standard Deviation 0.904
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment Average Reflux Syndrome Score	-0.09 Scores on a scale Standard Deviation 1.208	-0.13 Scores on a scale Standard Deviation 0.619	-0.20 Scores on a scale Standard Deviation 1.332	-0.26 Scores on a scale Standard Deviation 0.664	-0.16 Scores on a scale Standard Deviation 0.762	-0.43 Scores on a scale Standard Deviation 0.847
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment Average Total Score	0.01 Scores on a scale Standard Deviation 0.830	0.02 Scores on a scale Standard Deviation 0.668	0.07 Scores on a scale Standard Deviation 0.802	-0.11 Scores on a scale Standard Deviation 0.433	-0.23 Scores on a scale Standard Deviation 0.690	-0.28 Scores on a scale Standard Deviation 0.695

SECONDARY outcome

Timeframe: At Week 16

Population: ITT Population

Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Number of participants with Mean Worst Daily Itch Score of \<4 at Week 16 is presented.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=23 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=27 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=23 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Number of Participants With Mean Worst Daily Itch Score of <4 at Week 16	21 Participants	13 Participants	14 Participants	18 Participants	18 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline and At Week 16

Population: ITT Population

Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the most recent assessment completed by the participant prior to randomization. Number of participants with improvement of \>= 30% in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=23 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=27 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=23 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Number of Participants With Improvement of >= 30 Percent (%) in the Mean Worst Daily Itch Score at Week 16 From Baseline	17 Participants	9 Participants	15 Participants	14 Participants	15 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline and At Week 16

Population: ITT Population

Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the most recent assessment completed by the participant prior to randomization. Number of participants with improvement of \>=2 in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=23 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=27 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=23 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Number of Participants With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline	14 Participants	6 Participants	12 Participants	9 Participants	13 Participants	12 Participants

SECONDARY outcome

Timeframe: Up to Week 16

Population: ITT Population

Percentage of Responder Days with Worst Daily Itch score was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Percentage of responder days with Worst Daily Itch Score of \<4 is presented.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=23 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=27 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=23 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Percentage of Responder Days With Worst Daily Itch Score of <4	40.32 Percentage of days Interval 28.79 to 51.86	58.53 Percentage of days Interval 41.23 to 75.83	51.38 Percentage of days Interval 36.95 to 65.81	58.76 Percentage of days Interval 45.45 to 72.08	65.80 Percentage of days Interval 51.37 to 80.23	53.58 Percentage of days Interval 38.83 to 68.34

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: ITT Population

Percentage of Responder Days with Worst Daily Itch score was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Baseline is the most recent assessment completed by the participant prior to randomization. Percentage of responder days with improvement of \>= 30% in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented..

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=23 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=27 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=23 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Percentage of Responder Days With Improvement of >= 30% in the Mean Worst Daily Itch Score at Week 16 From Baseline	38.46 Percentage of days Interval 27.3 to 49.61	53.44 Percentage of days Interval 36.71 to 70.18	45.43 Percentage of days Interval 31.47 to 59.39	50.23 Percentage of days Interval 37.35 to 63.12	60.29 Percentage of days Interval 46.33 to 74.25	60.03 Percentage of days Interval 45.76 to 74.31

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: ITT Population

Percentage of Responder Days with Worst Daily Itch was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Baseline is the most recent assessment completed by the participant prior to randomization. Percentage of responder days with improvement of \>=2 in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=23 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=27 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=23 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Percentage of Responder Days With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline	31.56 Percentage of days Interval 19.96 to 43.16	37.71 Percentage of days Interval 20.31 to 55.11	38.82 Percentage of days Interval 24.31 to 53.33	40.69 Percentage of days Interval 27.29 to 54.08	51.49 Percentage of days Interval 36.98 to 66.0	58.60 Percentage of days Interval 43.76 to 73.43

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: ITT Population. Only those participants with data available at the specified data points were analyzed.

Mean Daily Sleep Score is defined as the average of the daily sleep scores provided in the 7 days prior to the relevant visit. Participants sleep quality was recorded in an electronic diary each morning using a 0-10 NRS in which 0: good sleep to 10:worst possible sleep. Higher score indicates worse possible sleep. Baseline is the average of the scores in the 7 days prior to the Week 4 (V3) visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=20 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=22 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=20 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Change From Baseline in the Mean Daily Sleep Score at Week 16	-1.39 Scores on a scale Interval -2.06 to -0.72	-1.66 Scores on a scale Interval -2.64 to -0.67	-1.87 Scores on a scale Interval -2.75 to -0.99	-1.85 Scores on a scale Interval -2.69 to -1.01	-2.35 Scores on a scale Interval -3.19 to -1.5	-1.69 Scores on a scale Interval -2.57 to -0.81

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: ITT Population. Only those participants with data available at the specified data points were analyzed.

Mean Daily Fatigue Score is defined as the average of the daily fatigue scores provided in the 7 days prior to the relevant visit. Participants fatigue level was recorded in an electronic diary each evening using a 0-10 NRS in which 0: no fatigue to 10:worst possible fatigue. Higher score indicates worse possible fatigue. Baseline is the average of the scores in the 7 days prior to the Week 4 (V3) visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=20 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=22 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=21 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Change From Baseline in the Mean Daily Fatigue Score at Week 16	-0.79 Scores on a scale Interval -1.39 to -0.18	-1.18 Scores on a scale Interval -2.08 to -0.27	-1.19 Scores on a scale Interval -2.0 to -0.37	-1.04 Scores on a scale Interval -1.81 to -0.28	-1.20 Scores on a scale Interval -1.97 to -0.44	-1.07 Scores on a scale Interval -1.86 to -0.29

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: ITT Population. Only those participants with data available at the specified data points were analyzed.

The 5-D itch scale had been developed as a brief, single page, instrument for the multidimensional quantification of itch that is sensitive to change over time. It has data to support its validity in a population of participants with pruritus and covers five dimensions of itch experienced by participants: duration, degree, direction, disability and distribution. Each domain was scored on a 5-point scale, ranging from 1 (Not present/resolved/never) to 5 (unbearable/getting worse/always), higher scores indicates worst itching. The scores of each of five domains were achieved separately and then summed together to obtain a total 5-D score. A total 5-D scores potentially ranged between 5 (no pruritus) and 25 (most severe pruritus) where higher score indicates worse possible itching. Baseline is assessment performed at Week 4 (V3) which is conducted prior to first dosing of randomized medication that evening. Change from Baseline was calculated as post-Baseline value minus Baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=21 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=21 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=20 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 Duration	-0.8 Scores on a scale Interval -1.1 to -0.4	-0.9 Scores on a scale Interval -1.3 to -0.4	-0.4 Scores on a scale Interval -0.8 to 0.0	-1.2 Scores on a scale Interval -1.6 to -0.8	-0.6 Scores on a scale Interval -1.0 to -0.2	-0.7 Scores on a scale Interval -1.1 to -0.3
Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 Degree	-0.7 Scores on a scale Interval -1.0 to -0.4	-0.9 Scores on a scale Interval -1.4 to -0.5	-0.7 Scores on a scale Interval -1.1 to -0.3	-0.7 Scores on a scale Interval -1.2 to -0.3	-0.9 Scores on a scale Interval -1.3 to -0.5	-0.8 Scores on a scale Interval -1.2 to -0.4
Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 Direction	-0.7 Scores on a scale Interval -1.1 to -0.3	-0.7 Scores on a scale Interval -1.3 to -0.1	-0.7 Scores on a scale Interval -1.2 to -0.2	-0.9 Scores on a scale Interval -1.4 to -0.4	-1.1 Scores on a scale Interval -1.6 to -0.6	-0.7 Scores on a scale Interval -1.2 to -0.2
Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 Disability	-0.4 Scores on a scale Interval -0.7 to 0.0	-0.8 Scores on a scale Interval -1.4 to -0.2	-0.5 Scores on a scale Interval -1.0 to 0.0	-0.7 Scores on a scale Interval -1.2 to -0.2	-0.7 Scores on a scale Interval -1.2 to -0.2	-0.7 Scores on a scale Interval -1.2 to -0.1
Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 Distribution	-0.4 Scores on a scale Interval -0.7 to -0.1	-0.7 Scores on a scale Interval -1.2 to -0.2	-0.7 Scores on a scale Interval -1.1 to -0.3	-0.9 Scores on a scale Interval -1.3 to -0.5	-0.7 Scores on a scale Interval -1.2 to -0.3	-0.6 Scores on a scale Interval -1.0 to -0.2
Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 5-D Itch Total Score	-3.0 Scores on a scale Interval -4.2 to -1.7	-4.0 Scores on a scale Interval -5.9 to -2.0	-3.0 Scores on a scale Interval -4.7 to -1.3	-4.4 Scores on a scale Interval -6.0 to -2.7	-3.8 Scores on a scale Interval -5.4 to -2.2	-3.5 Scores on a scale Interval -5.2 to -1.8

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: ITT Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected for evaluating total bile acid concentration as a biomarker of PBC. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=20 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=22 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=21 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=21 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Mean Change From Baseline at Week 16 in Serum Total Bile Acid Concentration	-4.274 Micromoles per Liter Standard Deviation 20.0163	-0.469 Micromoles per Liter Standard Deviation 6.5466	-3.878 Micromoles per Liter Standard Deviation 40.1857	-1.114 Micromoles per Liter Standard Deviation 6.9359	-2.133 Micromoles per Liter Standard Deviation 8.9308	7.379 Micromoles per Liter Standard Deviation 38.8282

SECONDARY outcome

Timeframe: Baseline and at Week 16

Population: ITT Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected for evaluating C4 concentration as a marker of bile acid synthesis. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=15 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=21 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=22 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=20 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Mean Change From Baseline at Week 16 in Serum 7-alpha Hydroxy-4-cholesten-3-one (C4)	4.746 Micrograms per Liter Standard Deviation 11.5644	10.703 Micrograms per Liter Standard Deviation 24.6045	11.452 Micrograms per Liter Standard Deviation 16.6371	29.488 Micrograms per Liter Standard Deviation 38.7584	58.674 Micrograms per Liter Standard Deviation 59.4833	40.629 Micrograms per Liter Standard Deviation 36.2769

SECONDARY outcome

Timeframe: At Week 4 (between 1 and 3 hours post-dose) and At Weeks 8, 12 and 16 (between 1 and 3 hours post-dose, and between 5 and 8 hours post-dose)

Population: Pharmacokinetic (PK) Population consisted of any randomized participant who had at least one PK sample. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Blood samples were collected for measurement of plasma GSK2330672 concentration.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=23 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=27 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=23 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Plasma Concentration of GSK2330672 After Sparse Sampling Week 16, Between 5 and 8 hours post-dose, n=3, 3, 4, 2, 5	296.33 Picograms per milliliter Standard Deviation 118.154	578.00 Picograms per milliliter Standard Deviation 651.263	1940.50 Picograms per milliliter Standard Deviation 1128.203	364.50 Picograms per milliliter Standard Deviation 217.082	869.40 Picograms per milliliter Standard Deviation 1148.331	—
Plasma Concentration of GSK2330672 After Sparse Sampling Week 4, Between 1 and 3 hours post-dose, n=6, 2, 7, 0, 4	5.00 Picograms per milliliter Standard Deviation NA Standard deviation could not be calculated as \>30% of samples were below the limit of quantification	5.00 Picograms per milliliter Standard Deviation NA Standard deviation could not be calculated as \>30% of samples were below the limit of quantification	32.71 Picograms per milliliter Standard Deviation 73.325	—	5.00 Picograms per milliliter Standard Deviation NA Standard deviation could not be calculated as \>30% of samples were below the limit of quantification	—
Plasma Concentration of GSK2330672 After Sparse Sampling Week 8, Between 1 and 3 hours post-dose, n=16, 21, 20, 22, 17	358.04 Picograms per milliliter Standard Deviation 665.685	958.81 Picograms per milliliter Standard Deviation 1563.265	2327.58 Picograms per milliliter Standard Deviation 3737.965	453.45 Picograms per milliliter Standard Deviation 967.424	2908.06 Picograms per milliliter Standard Deviation 5106.895	—
Plasma Concentration of GSK2330672 After Sparse Sampling Week 8, Between 5 and 8 hours post-dose, n=14, 17, 18, 21, 16	300.04 Picograms per milliliter Standard Deviation 356.268	820.87 Picograms per milliliter Standard Deviation 1143.023	2234.28 Picograms per milliliter Standard Deviation 3420.442	339.74 Picograms per milliliter Standard Deviation 357.914	1990.89 Picograms per milliliter Standard Deviation 4061.978	—
Plasma Concentration of GSK2330672 After Sparse Sampling Week 12, Between 1 and 3 hours post-dose, n=14, 19, 17, 20, 14	447.88 Picograms per milliliter Standard Deviation 1160.518	1594.16 Picograms per milliliter Standard Deviation 3133.370	2060.51 Picograms per milliliter Standard Deviation 2888.033	419.47 Picograms per milliliter Standard Deviation 774.321	3531.36 Picograms per milliliter Standard Deviation 6296.828	—
Plasma Concentration of GSK2330672 After Sparse Sampling Week 12, Between 5 and 8 hours post-dose, n=14, 16, 17, 20, 13	341.39 Picograms per milliliter Standard Deviation 638.359	1084.00 Picograms per milliliter Standard Deviation 1353.089	2569.00 Picograms per milliliter Standard Deviation 3727.883	303.83 Picograms per milliliter Standard Deviation 300.716	2197.16 Picograms per milliliter Standard Deviation 3604.704	—
Plasma Concentration of GSK2330672 After Sparse Sampling Week 16, Between 1 and 3 hours post-dose, n=3, 5, 4, 2, 5	394.00 Picograms per milliliter Standard Deviation 162.151	864.26 Picograms per milliliter Standard Deviation 1045.467	3328.50 Picograms per milliliter Standard Deviation 3185.646	338.50 Picograms per milliliter Standard Deviation 236.881	703.60 Picograms per milliliter Standard Deviation 756.010	—

POST_HOC outcome

Timeframe: Baseline and up to Week 12

Population: ITT Population. Only those participants with data available at the specified data points were analyzed.

Participants were required to score severity of their itching each morning and evening using a 0-10 NRS where 0(no itching) and 10(worst imaginable itching). The worst of these 2 scores was Worst Daily Itch Score. For each week, mean Worst Daily Itch Score was calculated to form Mean Worst Daily Itch Score. The Monthly Itch Score was defined as worst weekly score (e.g., Mean Worst Daily Itch Score) for that month. The monthly itch score ranges from 0 to 10, higher score indicates worst imaginable itching. Baseline is average of scores in the 7 days prior to Week 4 (Visit 3 \[V3\]). Change from Baseline was calculated as post-Baseline value minus Baseline value. Mean change from Baseline in monthly itch score over 12 week treatment period is presented. Analysis was performed on change in Monthly Itch Scores over 12 week treatment period using Mixed model repeated measures (MMRM) with Baseline itch, treatment group, visit and a treatment group\*visit interaction as covariates in the model.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=23 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=24 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Mean Change From Baseline in Monthly Itch Score	-0.46 Scores on a scale Interval -1.01 to 0.08	-1.17 Scores on a scale Interval -1.99 to -0.35	-1.08 Scores on a scale Interval -1.77 to -0.39	-1.36 Scores on a scale Interval -2.03 to -0.69	-1.63 Scores on a scale Interval -2.32 to -0.93	-1.41 Scores on a scale Interval -2.13 to -0.7

POST_HOC outcome

Timeframe: Baseline and up to Week 12

Population: ITT Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected for evaluation of total bile acid concentration as a biomarker of PBC. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 (Day 1) or Visit 1 (Screening), excluding unscheduled visits. Ratio to Baseline was defined as the geometric mean of post-Baseline visit value divided by the geometric mean of Baseline value. Values were log-transformed and mean change from Baseline on the log-scale was calculated over the 12 week treatment period. Analysis was performed on change in total serum bile acid concentration on the log-scale over the 12 week treatment period using Mixed model repeated measures (MMRM) with log-transformed Baseline total serum bile acid, visit, treatment group, a log-transformed Baseline total serum bile acid\*visit interaction, and a treatment group\*visit interaction used as covariates in the model. Afterwards, values were back-transformed to the original scale. Ratios of geometric means are presented.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=24 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Ratio to Baseline in Total Serum Bile Acid Concentration	1.01 Ratio Interval 0.801 to 1.273	0.977 Ratio Interval 0.688 to 1.386	1.182 Ratio Interval 0.874 to 1.6	0.918 Ratio Interval 0.687 to 1.226	0.697 Ratio Interval 0.519 to 0.938	0.833 Ratio Interval 0.616 to 1.127

POST_HOC outcome

Timeframe: Baseline and up to Week 12

Population: ITT Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected for evaluation of C4 concentration as a marker of bile acid synthesis. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 (Day 1) or Visit 1 (Screening), excluding unscheduled visits. Ratio to Baseline was defined as the geometric mean of post-Baseline visit value divided by the geometric mean of Baseline value. Values were log-transformed and mean change from Baseline on the log-scale was calculated over the 12 week treatment period. Analysis was performed on change in C4 on the log-scale over the 12 week treatment period using Mixed model repeated measures (MMRM) with log-transformed Baseline C4, visit, treatment group, a log-transformed Baseline C4\*visit interaction, and a treatment group\*visit interaction used as covariates in the model. Afterwards, values were back-transformed to the original scale. Ratios of geometric means are presented.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks.	GSK2330672 20 mg QD n=16 Participants Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg QD n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route	GSK2330672 180 mg QD n=24 Participants Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 40 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route.	GSK2330672 90 mg BID n=22 Participants Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route.
Ratio to Baseline in Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Concentration	1.158 Ratio Interval 0.937 to 1.431	1.579 Ratio Interval 1.151 to 2.166	2.374 Ratio Interval 1.812 to 3.109	2.846 Ratio Interval 2.192 to 3.694	3.622 Ratio Interval 2.753 to 4.764	3.127 Ratio Interval 2.385 to 4.101

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo - Main Study Period n=36 participants at risk Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 12 weeks in Main Study Period.	GSK2330672 20 mg QD - Main Study Period n=16 participants at risk Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period.	GSK2330672 90 mg QD - Main Study Period n=23 participants at risk Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period.	GSK2330672 180 mg QD - Main Study Period n=27 participants at risk Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period.	GSK2330672 40 mg BID - Main Study Period n=23 participants at risk Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period.	GSK2330672 90 mg BID - Main Study Period n=22 participants at risk Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period.	Placebo - Final Study Period n=35 participants at risk Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period.	GSK2330672 20 mg QD - Final Study Period n=16 participants at risk Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 20 mg QD during Main study period.	GSK2330672 90 mg QD - Final Study Period n=19 participants at risk Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 90 mg QD during Main study period.	GSK2330672 180 mg QD - Final Study Period n=19 participants at risk Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 180 mg QD during Main study period.	GSK2330672 40 mg BID - Final Study Period n=21 participants at risk Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 40 mg BID during Main study period.	GSK2330672 90 mg BID - Final Study Period n=17 participants at risk Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 90 mg BID during Main study period.	Placebo - Follow-up n=35 participants at risk Participants who received GSK2330672 matching placebo in Main study period and Final study period entered in a 4-week no-treatment follow-up period.	GSK2330672 20 mg QD - Follow-up n=16 participants at risk Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.	GSK2330672 90 mg QD - Follow-up n=23 participants at risk Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.	GSK2330672 180 mg QD - Follow-up n=27 participants at risk Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.	GSK2330672 40 mg BID - Follow-up n=22 participants at risk Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.	GSK2330672 90 mg BID - Follow-up n=22 participants at risk Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.
Gastrointestinal disorders Constipation	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	3.7% 1/27 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Lower respiratory tract infection	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.

Other adverse events

Other adverse events
Measure	Placebo - Main Study Period n=36 participants at risk Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 12 weeks in Main Study Period.	GSK2330672 20 mg QD - Main Study Period n=16 participants at risk Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period.	GSK2330672 90 mg QD - Main Study Period n=23 participants at risk Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period.	GSK2330672 180 mg QD - Main Study Period n=27 participants at risk Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period.	GSK2330672 40 mg BID - Main Study Period n=23 participants at risk Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period.	GSK2330672 90 mg BID - Main Study Period n=22 participants at risk Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period.	Placebo - Final Study Period n=35 participants at risk Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period.	GSK2330672 20 mg QD - Final Study Period n=16 participants at risk Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 20 mg QD during Main study period.	GSK2330672 90 mg QD - Final Study Period n=19 participants at risk Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 90 mg QD during Main study period.	GSK2330672 180 mg QD - Final Study Period n=19 participants at risk Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 180 mg QD during Main study period.	GSK2330672 40 mg BID - Final Study Period n=21 participants at risk Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 40 mg BID during Main study period.	GSK2330672 90 mg BID - Final Study Period n=17 participants at risk Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 90 mg BID during Main study period.	Placebo - Follow-up n=35 participants at risk Participants who received GSK2330672 matching placebo in Main study period and Final study period entered in a 4-week no-treatment follow-up period.	GSK2330672 20 mg QD - Follow-up n=16 participants at risk Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.	GSK2330672 90 mg QD - Follow-up n=23 participants at risk Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.	GSK2330672 180 mg QD - Follow-up n=27 participants at risk Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.	GSK2330672 40 mg BID - Follow-up n=22 participants at risk Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.	GSK2330672 90 mg BID - Follow-up n=22 participants at risk Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Sinusitis	5.6% 2/36 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	8.7% 2/23 • Number of events 3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Skin bacterial infection	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Psychiatric disorders Sleep disorder	2.8% 1/36 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Upper respiratory tract infection	5.6% 2/36 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	8.7% 2/23 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Urinary tract infection	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.5% 1/22 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Viral pharyngitis	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Vitamin A deficiency	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Vomiting	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	11.1% 3/27 • Number of events 3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	9.1% 2/22 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal pain	8.3% 3/36 • Number of events 3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	18.8% 3/16 • Number of events 3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	17.4% 4/23 • Number of events 6 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	29.6% 8/27 • Number of events 9 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	8.7% 2/23 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	18.2% 4/22 • Number of events 5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	12.5% 2/16 • Number of events 4 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	7.4% 2/27 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Arthralgia	2.8% 1/36 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
General disorders Asthenia	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	3.7% 1/27 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Bone fissure	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Muscle spasms	5.6% 2/36 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Bronchitis	2.8% 1/36 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	3.7% 1/27 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Investigations Cardiac murmur	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Eye disorders Cataract	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Constipation	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	17.4% 4/23 • Number of events 4 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Diarrhoea	11.1% 4/36 • Number of events 5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	37.5% 6/16 • Number of events 8 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	65.2% 15/23 • Number of events 20 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	66.7% 18/27 • Number of events 22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	52.2% 12/23 • Number of events 14 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	68.2% 15/22 • Number of events 15 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	2.9% 1/35 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.8% 1/21 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
General disorders Impaired healing	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Eye disorders Dry eye	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Dry mouth	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Dyspepsia	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	7.4% 2/27 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.5% 1/22 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
General disorders Fatigue	8.3% 3/36 • Number of events 3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	8.7% 2/23 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	7.4% 2/27 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.5% 1/22 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Flatulence	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	3.7% 1/27 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.8% 1/36 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Gingivitis	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Haemorrhoids	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Nervous system disorders Headache	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	13.0% 3/23 • Number of events 5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	7.4% 2/27 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.5% 1/22 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Investigations Hepatic enzyme increased	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	8.7% 2/23 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Vascular disorders Hypertension	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Endocrine disorders Hypothyroidism	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Infectious mononucleosis	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	5.9% 1/17 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Psychiatric disorders Insomnia	2.8% 1/36 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Lower respiratory tract infection	5.6% 2/36 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Nervous system disorders Memory impairment	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	8.7% 2/23 • Number of events 3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Nasopharyngitis	2.8% 1/36 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	3.7% 1/27 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	13.6% 3/22 • Number of events 3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	8.7% 2/23 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Nausea	2.8% 1/36 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	14.8% 4/27 • Number of events 4 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	9.1% 2/22 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	2.9% 1/35 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Rash	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Oral candidiasis	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Pain in extremity	2.8% 1/36 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Pruritus	5.6% 2/36 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	8.7% 2/23 • Number of events 3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	3.7% 1/27 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	9.1% 2/22 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	2.9% 1/35 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	5.3% 1/19 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.8% 1/21 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	5.9% 1/17 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
General disorders Pyrexia	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	3.7% 1/27 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	4.3% 1/23 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	9.1% 2/22 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Rhinitis	0.00% 0/36 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/19 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/21 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/17 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/35 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/23 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/27 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.	0.00% 0/22 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period. Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER