Trial Outcomes & Findings for A Study of the Combination Regimen Grazoprevir (MK-5172) and Elbasvir (MK-8742) ± Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035) (NCT NCT01717326)

NCT ID: NCT01717326

Last Updated: 2021-02-05

Results Overview

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR12 was defined as HCV RNA \<25 IU/ml at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 573 participants
• Primary outcome timeframe: 12 weeks after end of therapy (up to 30 weeks)
• Results posted on: 2021-02-05

Participant Flow

Male/female participants with Hepatitis C Virus (HCV) genotype 1 (GT1) or GT3 who were either treatment-naïve (TN) or prior null responder (NR), cirrhotic (C) or noncirrhotic (NC), and monoinfected with HCV or coinfected with HCV and human immunodeficiency virus (HIV) were recruited based on entry requirements for Parts A, B, C, or D.

573 participants were randomized on study. 65 TN NC GT1 participants were randomized in Part A. Part B randomized 94 TN NC participants, 123 TN C participants, 130 NR participants (C and NC), and 59 TN HIV coinfected participants. Part C randomized 61 TN NC GT1b participants, and Part D randomized 41 TN NC GT3 participants.

Participant milestones

Measure	A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.	D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
Overall Study STARTED	25	27	13	30	33	31	31	29	32	31	32	33	33	32	29	30	30	31	20	21
Overall Study Treated	25	28	12	30	33	31	31	29	32	31	32	33	33	32	29	30	30	31	20	21
Overall Study COMPLETED	22	26	13	28	31	31	30	29	32	29	30	33	32	32	29	27	29	31	16	15
Overall Study NOT COMPLETED	3	1	0	2	2	0	1	0	0	2	2	0	1	0	0	3	1	0	4	6

Reasons for withdrawal

Measure	A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.	D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
Overall Study Death	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Overall Study Lost to Follow-up	3	0	0	2	1	0	1	0	0	0	1	0	0	0	0	2	1	0	2	3
Overall Study Physician Decision	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Overall Study Protocol Violation	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study Withdrawal by Subject	0	1	0	0	0	0	0	0	0	1	0	0	1	0	0	1	0	0	2	3

Baseline Characteristics

A Study of the Combination Regimen Grazoprevir (MK-5172) and Elbasvir (MK-8742) ± Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035)

Baseline characteristics by cohort

Measure	A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk n=25 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=27 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=13 Participants GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=31 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk n=31 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.	D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=20 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=21 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	Total n=573 Participants Total of all reporting groups
Age, Continuous	48.7 years STANDARD_DEVIATION 12.5 • n=5 Participants	43.9 years STANDARD_DEVIATION 12.6 • n=7 Participants	43.3 years STANDARD_DEVIATION 13.5 • n=5 Participants	48.4 years STANDARD_DEVIATION 11.9 • n=4 Participants	49.7 years STANDARD_DEVIATION 11.5 • n=21 Participants	53.6 years STANDARD_DEVIATION 8.4 • n=8 Participants	57.0 years STANDARD_DEVIATION 7.0 • n=8 Participants	59.0 years STANDARD_DEVIATION 7.8 • n=24 Participants	58.8 years STANDARD_DEVIATION 8.2 • n=42 Participants	58.9 years STANDARD_DEVIATION 8.0 • n=42 Participants	52.2 years STANDARD_DEVIATION 8.8 • n=42 Participants	54.4 years STANDARD_DEVIATION 9.1 • n=42 Participants	56.2 years STANDARD_DEVIATION 10.9 • n=36 Participants	54.3 years STANDARD_DEVIATION 12.3 • n=36 Participants	46.2 years STANDARD_DEVIATION 8.4 • n=24 Participants	43.5 years STANDARD_DEVIATION 10.4 • n=135 Participants	50.6 years STANDARD_DEVIATION 10.9 • n=136 Participants	55.3 years STANDARD_DEVIATION 10.3 • n=44 Participants	49.0 years STANDARD_DEVIATION 11.5 • n=667 Participants	42.4 years STANDARD_DEVIATION 10.8 • n=15 Participants	51.9 years STANDARD_DEVIATION 11.3 • n=40 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	17 Participants n=7 Participants	6 Participants n=5 Participants	12 Participants n=4 Participants	15 Participants n=21 Participants	15 Participants n=8 Participants	12 Participants n=8 Participants	10 Participants n=24 Participants	17 Participants n=42 Participants	10 Participants n=42 Participants	12 Participants n=42 Participants	13 Participants n=42 Participants	17 Participants n=36 Participants	14 Participants n=36 Participants	6 Participants n=24 Participants	6 Participants n=135 Participants	14 Participants n=136 Participants	18 Participants n=44 Participants	12 Participants n=667 Participants	13 Participants n=15 Participants	252 Participants n=40 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	18 Participants n=4 Participants	18 Participants n=21 Participants	16 Participants n=8 Participants	19 Participants n=8 Participants	19 Participants n=24 Participants	15 Participants n=42 Participants	21 Participants n=42 Participants	20 Participants n=42 Participants	20 Participants n=42 Participants	16 Participants n=36 Participants	18 Participants n=36 Participants	23 Participants n=24 Participants	24 Participants n=135 Participants	16 Participants n=136 Participants	13 Participants n=44 Participants	8 Participants n=667 Participants	8 Participants n=15 Participants	321 Participants n=40 Participants

PRIMARY outcome

Timeframe: 12 weeks after end of therapy (up to 30 weeks)

Population: The Per-Protocol (PP) population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR12 was defined as HCV RNA <25 IU/ml at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.

Outcome measures

Measure	A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk n=22 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=24 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=12 Participants GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=29 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=31 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=28 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=29 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk n=31 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.	D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=19 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=18 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)	100.0 percentage of participants Interval 84.6 to 100.0	95.8 percentage of participants Interval 78.9 to 99.9	100.0 percentage of participants Interval 73.5 to 100.0	82.8 percentage of participants Interval 64.2 to 94.2	100.0 percentage of participants Interval 88.1 to 100.0	96.8 percentage of participants Interval 83.3 to 99.9	90.0 percentage of participants Interval 73.5 to 97.9	96.6 percentage of participants Interval 82.2 to 99.9	100.0 percentage of participants Interval 88.8 to 100.0	93.5 percentage of participants Interval 78.6 to 99.2	100.0 percentage of participants Interval 88.4 to 100.0	90.9 percentage of participants Interval 75.7 to 98.1	100.0 percentage of participants Interval 89.4 to 100.0	96.9 percentage of participants Interval 83.8 to 99.9	96.6 percentage of participants Interval 82.2 to 99.9	92.9 percentage of participants Interval 76.5 to 99.1	93.1 percentage of participants Interval 77.2 to 99.2	93.5 percentage of participants Interval 78.6 to 99.2	47.4 percentage of participants Interval 24.4 to 71.1	61.1 percentage of participants Interval 35.7 to 82.7

PRIMARY outcome

Timeframe: From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)

Population: All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.

Outcome measures

Measure	A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk n=25 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=28 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=12 Participants GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=31 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk n=31 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.	D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=20 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=21 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days	88.0 percentage of participants Interval 68.8 to 97.5	85.7 percentage of participants Interval 67.3 to 96.0	91.7 percentage of participants Interval 61.5 to 99.8	90.0 percentage of participants Interval 73.5 to 97.9	72.7 percentage of participants Interval 54.5 to 86.7	87.1 percentage of participants Interval 70.2 to 96.4	77.4 percentage of participants Interval 58.9 to 90.4	65.5 percentage of participants Interval 45.7 to 82.1	87.5 percentage of participants Interval 71.0 to 96.5	83.9 percentage of participants Interval 66.3 to 94.5	81.3 percentage of participants Interval 63.6 to 92.8	78.8 percentage of participants Interval 61.1 to 91.0	97.0 percentage of participants Interval 84.2 to 99.9	81.3 percentage of participants Interval 63.6 to 92.8	65.5 percentage of participants Interval 45.7 to 82.1	53.3 percentage of participants Interval 34.3 to 71.7	73.3 percentage of participants Interval 54.1 to 87.7	54.8 percentage of participants Interval 36.0 to 72.7	85.0 percentage of participants Interval 62.1 to 96.8	90.5 percentage of participants Interval 69.6 to 98.8

PRIMARY outcome

Timeframe: From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)

Population: APaT population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.

Outcome measures

Measure	A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk n=25 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=28 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=12 Participants GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=31 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk n=31 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.	D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=20 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=21 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days	0.0 percentage of participants Interval 0.0 to 13.7	0.0 percentage of participants Interval 0.0 to 12.3	0.0 percentage of participants Interval 0.0 to 26.5	0.0 percentage of participants Interval 0.0 to 11.6	0.0 percentage of participants Interval 0.0 to 10.6	0.0 percentage of participants Interval 0.0 to 11.2	0.0 percentage of participants Interval 0.0 to 11.2	0.0 percentage of participants Interval 0.0 to 11.9	6.3 percentage of participants Interval 0.8 to 20.8	0.0 percentage of participants Interval 0.0 to 11.2	3.1 percentage of participants Interval 0.1 to 16.2	0.0 percentage of participants Interval 0.0 to 10.6	0.0 percentage of participants Interval 0.0 to 10.6	0.0 percentage of participants Interval 0.0 to 10.9	0.0 percentage of participants Interval 0.0 to 11.9	0.0 percentage of participants Interval 0.0 to 11.6	0.0 percentage of participants Interval 0.0 to 11.6	0.0 percentage of participants Interval 0.0 to 11.2	0.0 percentage of participants Interval 0.0 to 16.8	4.8 percentage of participants Interval 0.1 to 23.8

SECONDARY outcome

Timeframe: From first dose of study medication until first achievement of undetectable HCV RNA (up to 18 weeks of treatment)

Population: FAS; all randomized participants who received ≥1 dose of study treatment.

Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Kaplan Meier summary statistics were used to characterize the time to first achievement of undetectable HCV RNA.

Outcome measures

Measure	A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk n=25 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=27 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=13 Participants GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=31 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk n=31 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.	D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=20 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=21 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
Mean Time to First Achievement of Undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA)	21.7 days Standard Error 2.2	19.2 days Standard Error 1.8	23.4 days Standard Error 2.9	27.9 days Standard Error 3.0	30.7 days Standard Error 2.3	32.0 days Standard Error 3.0	37.0 days Standard Error 2.8	33.2 days Standard Error 2.4	33.1 days Standard Error 2.8	33.7 days Standard Error 2.6	31.9 days Standard Error 2.2	37.4 days Standard Error 2.5	37.4 days Standard Error 2.7	42.7 days Standard Error 3.3	27.6 days Standard Error 3.0	29.0 days Standard Error 2.9	23.7 days Standard Error 2.1	34.5 days Standard Error 2.6	30.1 days Standard Error 3.7	19.8 days Standard Error 2.3

SECONDARY outcome

Timeframe: Week 2

Population: The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.

Outcome measures

Measure	A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk n=23 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=25 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=12 Participants GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=29 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=31 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk n=31 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.	D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=20 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=20 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
Percentage of Participants Achieving Undetectable HCV RNA at Week 2	52.2 percentage of participants Interval 30.6 to 73.2	44.0 percentage of participants Interval 24.4 to 65.1	41.7 percentage of participants Interval 15.2 to 72.3	44.8 percentage of participants Interval 26.4 to 64.3	20.0 percentage of participants Interval 7.7 to 38.6	16.1 percentage of participants Interval 5.5 to 33.7	6.7 percentage of participants Interval 0.8 to 22.1	10.3 percentage of participants Interval 2.2 to 27.4	25.0 percentage of participants Interval 11.5 to 43.4	16.1 percentage of participants Interval 5.5 to 33.7	12.9 percentage of participants Interval 3.6 to 29.8	6.1 percentage of participants Interval 0.7 to 20.2	6.1 percentage of participants Interval 0.7 to 20.2	6.3 percentage of participants Interval 0.8 to 20.8	37.9 percentage of participants Interval 20.7 to 57.7	40.0 percentage of participants Interval 22.7 to 59.4	46.7 percentage of participants Interval 28.3 to 65.7	12.9 percentage of participants Interval 3.6 to 29.8	40.0 percentage of participants Interval 19.1 to 63.9	70.0 percentage of participants Interval 45.7 to 88.1

SECONDARY outcome

Timeframe: Week 4

Population: The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.

Outcome measures

Measure	A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk n=23 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=24 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=12 Participants GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=31 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=28 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk n=31 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.	D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=20 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=18 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
Percentage of Participants Achieving Undetectable HCV RNA at Week 4	73.9 percentage of participants Interval 51.6 to 89.8	91.7 percentage of participants Interval 73.0 to 99.0	75.0 percentage of participants Interval 42.8 to 94.5	73.3 percentage of participants Interval 54.1 to 87.7	83.3 percentage of participants Interval 65.3 to 94.4	77.4 percentage of participants Interval 58.9 to 90.4	60.0 percentage of participants Interval 40.6 to 77.3	79.3 percentage of participants Interval 60.3 to 92.0	71.9 percentage of participants Interval 53.3 to 86.3	71.0 percentage of participants Interval 52.0 to 85.8	83.3 percentage of participants Interval 65.3 to 94.4	68.8 percentage of participants Interval 50.0 to 83.9	69.7 percentage of participants Interval 51.3 to 84.4	53.1 percentage of participants Interval 34.7 to 70.9	75.9 percentage of participants Interval 56.5 to 89.7	78.6 percentage of participants Interval 59.0 to 91.7	86.7 percentage of participants Interval 69.3 to 96.2	74.2 percentage of participants Interval 55.4 to 88.1	50.0 percentage of participants Interval 27.2 to 72.8	77.8 percentage of participants Interval 52.4 to 93.6

SECONDARY outcome

Timeframe: Week 12

Population: The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis.

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.

Outcome measures

Measure	A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk n=22 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=24 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=12 Participants GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=31 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=28 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.	D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=19 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=20 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
Percentage of Participants Achieving Undetectable HCV RNA at Week 12	100.0 percentage of participants Interval 84.6 to 100.0	100.0 percentage of participants Interval 85.8 to 100.0	100.0 percentage of participants Interval 73.5 to 100.0	—	100.0 percentage of participants Interval 88.1 to 100.0	100.0 percentage of participants Interval 88.8 to 100.0	93.3 percentage of participants Interval 77.9 to 99.2	96.6 percentage of participants Interval 82.2 to 99.9	100.0 percentage of participants Interval 88.8 to 100.0	100.0 percentage of participants Interval 88.8 to 100.0	100.0 percentage of participants Interval 88.4 to 100.0	93.8 percentage of participants Interval 79.2 to 99.2	100.0 percentage of participants Interval 89.4 to 100.0	96.9 percentage of participants Interval 83.8 to 99.9	93.1 percentage of participants Interval 77.2 to 99.2	92.9 percentage of participants Interval 76.5 to 99.1	—	—	47.7 percentage of participants Interval 24.4 to 71.1	65.0 percentage of participants Interval 40.8 to 84.6

SECONDARY outcome

Timeframe: Week 2

Population: The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.

Outcome measures

Measure	A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk n=23 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=25 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=12 Participants GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=29 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=31 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk n=31 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.	D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=20 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=20 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 2	91.3 percentage of participants Interval 72.0 to 98.9	92.0 percentage of participants Interval 74.0 to 99.0	91.7 percentage of participants Interval 61.5 to 99.8	86.2 percentage of participants Interval 68.3 to 96.1	73.3 percentage of participants Interval 54.1 to 87.7	77.4 percentage of participants Interval 58.9 to 90.4	60.0 percentage of participants Interval 40.6 to 77.3	79.3 percentage of participants Interval 60.3 to 92.0	78.1 percentage of participants Interval 60.0 to 90.7	67.7 percentage of participants Interval 48.6 to 83.3	77.4 percentage of participants Interval 58.9 to 90.4	66.7 percentage of participants Interval 48.2 to 82.0	57.6 percentage of participants Interval 39.2 to 74.5	62.5 percentage of participants Interval 43.7 to 78.9	89.7 percentage of participants Interval 72.6 to 97.8	76.7 percentage of participants Interval 57.7 to 90.1	76.7 percentage of participants Interval 57.7 to 90.1	61.3 percentage of participants Interval 42.2 to 78.2	70.0 percentage of participants Interval 45.7 to 88.1	85.0 percentage of participants Interval 62.1 to 96.8

SECONDARY outcome

Timeframe: Week 4

Population: The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.

Outcome measures

Measure	A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk n=23 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=24 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=12 Participants GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=31 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=28 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk n=31 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.	D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=20 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=18 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 4	100.0 percentage of participants Interval 85.2 to 100.0	100.0 percentage of participants Interval 85.8 to 100.0	100.0 percentage of participants Interval 73.5 to 100.0	100.0 percentage of participants Interval 88.4 to 100.0	100.0 percentage of participants Interval 88.4 to 100.0	100.0 percentage of participants Interval 88.8 to 100.0	90.0 percentage of participants Interval 73.5 to 97.9	100.0 percentage of participants Interval 88.1 to 100.0	100.0 percentage of participants Interval 89.1 to 100.0	90.3 percentage of participants Interval 74.2 to 98.0	100.0 percentage of participants Interval 88.4 to 100.0	96.9 percentage of participants Interval 83.8 to 99.9	97.0 percentage of participants Interval 84.2 to 99.9	93.8 percentage of participants Interval 79.2 to 99.2	100.0 percentage of participants Interval 88.1 to 100.0	100.0 percentage of participants Interval 87.7 to 100.0	100.0 percentage of participants Interval 88.4 to 100.0	96.8 percentage of participants Interval 83.3 to 99.9	65.0 percentage of participants Interval 40.8 to 84.6	83.3 percentage of participants Interval 58.6 to 96.4

SECONDARY outcome

Timeframe: Week 12

Population: The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis.

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.

Outcome measures

Measure	A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk n=22 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=24 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=12 Participants GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=31 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=28 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.	D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=19 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=20 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 12	100.0 percentage of participants Interval 84.6 to 100.0	100.0 percentage of participants Interval 85.8 to 100.0	100.0 percentage of participants Interval 73.5 to 100.0	—	100.0 percentage of participants Interval 88.1 to 100.0	100.0 percentage of participants Interval 88.8 to 100.0	93.3 percentage of participants Interval 77.9 to 99.2	100.0 percentage of participants Interval 88.1 to 100.0	100.0 percentage of participants Interval 88.8 to 100.0	100.0 percentage of participants Interval 88.8 to 100.0	100.0 percentage of participants Interval 88.4 to 100.0	100.0 percentage of participants Interval 89.1 to 100.0	100.0 percentage of participants Interval 89.4 to 100.0	96.9 percentage of participants Interval 83.8 to 99.9	100.0 percentage of participants Interval 88.1 to 100.0	92.9 percentage of participants Interval 76.5 to 99.1	—	—	47.4 percentage of participants Interval 24.4 to 71.1	75.0 percentage of participants Interval 50.9 to 91.3

SECONDARY outcome

Timeframe: 4 weeks after end of therapy (up to 22 weeks)

Population: The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR4 was defined as HCV RNA <25 IU/ml at 4 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.

Outcome measures

Measure	A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk n=22 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=24 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=12 Participants GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=31 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=29 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk n=31 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.	D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=20 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=18 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After the End of All Therapy (SVR4)	100.0 percentage of participants Interval 84.6 to 100.0	95.8 percentage of participants Interval 78.9 to 99.9	100.0 percentage of participants Interval 73.5 to 100.0	93.3 percentage of participants Interval 77.9 to 99.2	100.0 percentage of participants Interval 88.1 to 100.0	96.8 percentage of participants Interval 83.3 to 99.9	96.7 percentage of participants Interval 82.8 to 99.9	96.6 percentage of participants Interval 82.2 to 99.9	100.0 percentage of participants Interval 88.8 to 100.0	96.8 percentage of participants Interval 83.3 to 99.9	100.0 percentage of participants Interval 88.4 to 100.0	93.9 percentage of participants Interval 79.8 to 99.3	100.0 percentage of participants Interval 89.4 to 100.0	96.9 percentage of participants Interval 83.8 to 99.9	96.6 percentage of participants Interval 82.2 to 99.9	93.1 percentage of participants Interval 77.2 to 99.2	93.1 percentage of participants Interval 77.2 to 99.2	96.8 percentage of participants Interval 83.3 to 99.9	50.0 percentage of participants Interval 27.2 to 72.8	61.1 percentage of participants Interval 35.7 to 82.7

SECONDARY outcome

Timeframe: 24 weeks after end of therapy (up to 42 weeks)

Population: The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR24 was defined as HCV RNA <25 IU/ml at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.

Outcome measures

Measure	A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk n=20 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=24 Participants GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=12 Participants GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=28 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=31 Participants GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=30 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=31 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=33 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=32 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=27 Participants GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=29 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk n=31 Participants GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.	D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=19 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=17 Participants GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)	100.0 percentage of participants Interval 83.2 to 100.0	95.8 percentage of participants Interval 78.9 to 99.9	100.0 percentage of participants Interval 73.5 to 100.0	78.6 percentage of participants Interval 59.0 to 91.7	100.0 percentage of participants Interval 88.1 to 100.0	96.8 percentage of participants Interval 83.3 to 99.9	90.0 percentage of participants Interval 73.5 to 97.9	96.6 percentage of participants Interval 82.2 to 99.9	100.0 percentage of participants Interval 88.8 to 100.0	93.1 percentage of participants Interval 77.2 to 99.2	100.0 percentage of participants Interval 88.1 to 100.0	90.9 percentage of participants Interval 75.7 to 98.1	100.0 percentage of participants Interval 89.1 to 100.0	96.9 percentage of participants Interval 83.8 to 99.9	96.6 percentage of participants Interval 82.2 to 99.9	88.9 percentage of participants Interval 70.8 to 97.6	93.1 percentage of participants Interval 77.2 to 99.2	93.5 percentage of participants Interval 78.6 to 99.2	47.4 percentage of participants Interval 24.4 to 71.1	58.8 percentage of participants Interval 32.9 to 81.6

Adverse Events

A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk n=25 participants at risk GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=28 participants at risk GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=12 participants at risk GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 participants at risk GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=33 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=31 participants at risk GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=31 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk n=29 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=32 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=31 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk n=32 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=33 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=33 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=32 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=30 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 participants at risk GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk n=31 participants at risk GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.	D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=20 participants at risk GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=21 participants at risk GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
Cardiac disorders Atrial fibrillation	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Gastrointestinal disorders Abdominal pain	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Gastrointestinal disorders Gastritis	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Gastrointestinal disorders Nausea	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
General disorders Asthenia	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
General disorders Chest pain	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Hepatobiliary disorders Cholangitis	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Hepatobiliary disorders Cholecystitis acute	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Infections and infestations Bacteraemia	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Infections and infestations Scrotal abscess	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Infections and infestations Staphylococcal infection	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Psychiatric disorders Depression	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Renal and urinary disorders Hydronephrosis	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).

Other adverse events

Measure	A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk n=25 participants at risk GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=28 participants at risk GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=12 participants at risk GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 participants at risk GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=33 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=31 participants at risk GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=31 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk n=29 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=32 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=31 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk n=32 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=33 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=33 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk n=32 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.	B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=29 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk n=30 participants at risk GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.	C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk n=30 participants at risk GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk n=31 participants at risk GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.	D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk n=20 participants at risk GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.	D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk n=21 participants at risk GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
Gastrointestinal disorders Tooth impacted	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Blood and lymphatic system disorders Anaemia	12.0% 3/25 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	7.1% 2/28 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.5% 4/32 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	15.2% 5/33 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.9% 2/29 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	15.0% 3/20 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Cardiac disorders Palpitations	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	5.0% 1/20 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Ear and labyrinth disorders Ear pain	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Gastrointestinal disorders Abdominal pain	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	7.1% 2/28 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	5.0% 1/20 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	14.3% 3/21 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Gastrointestinal disorders Abdominal pain upper	20.0% 5/25 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	7.1% 2/28 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.7% 2/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.1% 3/33 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.7% 3/31 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.4% 3/32 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.1% 3/33 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	15.6% 5/32 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	5.0% 1/20 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.5% 2/21 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Gastrointestinal disorders Constipation	4.0% 1/25 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.1% 3/33 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.1% 4/33 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Gastrointestinal disorders Diarrhoea	12.0% 3/25 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	17.9% 5/28 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	16.7% 5/30 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.9% 4/31 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.9% 2/29 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.5% 4/32 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.1% 3/33 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	21.9% 7/32 • Number of events 7 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	5.0% 1/20 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Gastrointestinal disorders Dry mouth	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.7% 2/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	5.0% 1/20 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Gastrointestinal disorders Dyspepsia	12.0% 3/25 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	7.1% 2/28 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.1% 3/33 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	14.3% 3/21 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Gastrointestinal disorders Flatulence	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.6% 1/28 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Gastrointestinal disorders Frequent bowel movements	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Gastrointestinal disorders Gastrooesophageal reflux disease	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	5.0% 1/20 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Gastrointestinal disorders Nausea	20.0% 5/25 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	25.0% 7/28 • Number of events 7 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	16.7% 2/12 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	26.7% 8/30 • Number of events 8 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	18.2% 6/33 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	16.1% 5/31 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.9% 4/31 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.5% 4/32 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.9% 4/31 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.5% 4/32 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	15.2% 5/33 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	20.0% 6/30 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.7% 3/31 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	15.0% 3/20 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	28.6% 6/21 • Number of events 7 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Gastrointestinal disorders Vomiting	8.0% 2/25 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	14.3% 4/28 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.7% 2/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.9% 2/29 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.4% 3/32 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.1% 3/33 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	14.3% 3/21 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
General disorders Asthenia	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.1% 3/33 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.7% 3/31 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	15.6% 5/32 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	21.9% 7/32 • Number of events 7 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	15.2% 5/33 • Number of events 7 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	18.2% 6/33 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	21.9% 7/32 • Number of events 7 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	13.8% 4/29 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	10.0% 2/20 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	14.3% 3/21 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
General disorders Chills	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
General disorders Fatigue	36.0% 9/25 • Number of events 9 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	17.9% 5/28 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	33.3% 4/12 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	50.0% 15/30 • Number of events 15 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	30.3% 10/33 • Number of events 10 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	19.4% 6/31 • Number of events 7 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	35.5% 11/31 • Number of events 11 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	20.7% 6/29 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	28.1% 9/32 • Number of events 10 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	19.4% 6/31 • Number of events 7 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	18.8% 6/32 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	30.3% 10/33 • Number of events 12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	45.5% 15/33 • Number of events 16 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	25.0% 8/32 • Number of events 8 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.9% 2/29 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.7% 2/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	36.7% 11/30 • Number of events 11 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.7% 3/31 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	10.0% 2/20 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	14.3% 3/21 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
General disorders Influenza like illness	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
General disorders Malaise	8.0% 2/25 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
General disorders Oedema peripheral	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
General disorders Pain	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
General disorders Peripheral swelling	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Infections and infestations Bronchitis	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.7% 2/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.1% 4/33 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Infections and infestations Ear infection	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Infections and infestations Gastroenteritis	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Infections and infestations Influenza	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Infections and infestations Nasopharyngitis	8.0% 2/25 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.1% 3/33 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.9% 4/31 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.4% 3/32 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	15.2% 5/33 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Infections and infestations Oral herpes	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.5% 2/21 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Infections and infestations Sinusitis	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	10.7% 3/28 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.9% 2/29 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Infections and infestations Upper respiratory tract infection	8.0% 2/25 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.6% 1/28 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	10.0% 3/30 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.9% 2/29 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.4% 3/32 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	15.0% 3/20 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	23.8% 5/21 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Infections and infestations Urinary tract infection	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	7.1% 2/28 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Injury, poisoning and procedural complications Accidental overdose	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.6% 1/28 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	10.0% 3/30 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.1% 4/33 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	16.1% 5/31 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.4% 3/32 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.7% 2/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	15.0% 3/20 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.5% 2/21 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Injury, poisoning and procedural complications Contusion	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Investigations Alanine aminotransferase increased	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	7.1% 2/28 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Investigations Amylase increased	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.9% 2/29 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Investigations Aspartate aminotransferase increased	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	7.1% 2/28 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Investigations Blood creatine phosphokinase increased	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Investigations International normalised ratio increased	12.0% 3/25 • Number of events 8 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Investigations Lipase increased	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.9% 2/29 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Metabolism and nutrition disorders Decreased appetite	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.6% 1/28 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	13.3% 4/30 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.9% 2/29 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	5.0% 1/20 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Musculoskeletal and connective tissue disorders Arthralgia	8.0% 2/25 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.6% 1/28 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	10.3% 3/29 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.1% 4/33 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.5% 4/32 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Musculoskeletal and connective tissue disorders Back pain	8.0% 2/25 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.9% 2/29 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.5% 4/32 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.4% 3/32 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	15.6% 5/32 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	5.0% 1/20 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.7% 2/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Musculoskeletal and connective tissue disorders Muscular weakness	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Musculoskeletal and connective tissue disorders Myalgia	8.0% 2/25 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.6% 1/28 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	16.7% 2/12 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	18.2% 6/33 • Number of events 8 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	18.2% 6/33 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.5% 4/32 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.7% 3/31 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Nervous system disorders Disturbance in attention	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	10.0% 3/30 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Nervous system disorders Dizziness	16.0% 4/25 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	7.1% 2/28 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	10.0% 3/30 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.7% 3/31 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.9% 2/29 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.9% 4/31 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.7% 2/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	5.0% 1/20 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Nervous system disorders Dysgeusia	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Nervous system disorders Headache	16.0% 4/25 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	21.4% 6/28 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	41.7% 5/12 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	23.3% 7/30 • Number of events 7 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	21.2% 7/33 • Number of events 9 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	32.3% 10/31 • Number of events 11 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	13.8% 4/29 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	34.4% 11/32 • Number of events 13 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	32.3% 10/31 • Number of events 12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	31.2% 10/32 • Number of events 12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	18.2% 6/33 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	18.2% 6/33 • Number of events 7 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	31.2% 10/32 • Number of events 10 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	13.8% 4/29 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.7% 2/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	20.0% 6/30 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	16.1% 5/31 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	25.0% 5/20 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	23.8% 5/21 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Nervous system disorders Somnolence	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Nervous system disorders Tremor	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Psychiatric disorders Affect lability	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.7% 2/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Psychiatric disorders Agitation	8.0% 2/25 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Psychiatric disorders Anxiety	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.6% 1/28 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.1% 3/33 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.1% 3/33 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	5.0% 1/20 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Psychiatric disorders Depression	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	16.7% 2/12 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	10.0% 3/30 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Psychiatric disorders Insomnia	12.0% 3/25 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	7.1% 2/28 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	10.0% 3/30 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	21.2% 7/33 • Number of events 8 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	16.1% 5/31 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.9% 2/29 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.5% 4/32 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.1% 3/33 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	18.2% 6/33 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.9% 2/29 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	15.0% 3/20 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	14.3% 3/21 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Psychiatric disorders Irritability	8.0% 2/25 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.6% 1/28 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.7% 2/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.7% 2/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Psychiatric disorders Mood swings	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	10.0% 3/30 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Psychiatric disorders Nightmare	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Psychiatric disorders Sleep disorder	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.7% 3/31 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.9% 4/31 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	13.8% 4/29 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Renal and urinary disorders Chromaturia	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Respiratory, thoracic and mediastinal disorders Cough	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	7.1% 2/28 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.9% 2/29 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	18.8% 6/32 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	15.6% 5/32 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	15.2% 5/33 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.9% 2/29 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	5.0% 1/20 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 5/25 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.6% 1/28 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	13.3% 4/30 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	15.6% 5/32 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	18.2% 6/33 • Number of events 7 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.7% 2/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	14.3% 3/21 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.7% 2/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.1% 3/33 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Respiratory, thoracic and mediastinal disorders Epistaxis	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.4% 3/32 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.5% 2/21 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.7% 2/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Skin and subcutaneous tissue disorders Alopecia	8.0% 2/25 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.6% 1/28 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Skin and subcutaneous tissue disorders Dermatitis contact	8.0% 2/25 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.7% 2/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.5% 4/32 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.1% 4/33 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	4.8% 1/21 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.2% 2/32 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.0% 1/33 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	5.0% 1/20 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.5% 2/21 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Skin and subcutaneous tissue disorders Pruritus	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	7.1% 2/28 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	20.0% 6/30 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	12.1% 4/33 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	15.6% 5/32 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	30.3% 10/33 • Number of events 10 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	10.3% 3/29 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	13.3% 4/30 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	5.0% 1/20 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	14.3% 3/21 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Skin and subcutaneous tissue disorders Rash	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	17.9% 5/28 • Number of events 5 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	8.3% 1/12 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.1% 3/33 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.7% 3/31 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	21.9% 7/32 • Number of events 8 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.4% 3/32 • Number of events 4 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.1% 3/33 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.1% 3/33 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	10.0% 3/30 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	15.0% 3/20 • Number of events 6 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	9.5% 2/21 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/25 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.7% 2/30 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Vascular disorders Flushing	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.5% 2/31 • Number of events 3 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/32 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
Vascular disorders Hypertension	4.0% 1/25 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/28 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/12 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	6.1% 2/33 • Number of events 2 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.2% 1/31 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.4% 1/29 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/33 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.1% 1/32 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/29 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	3.3% 1/30 • Number of events 1 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/30 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/31 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/20 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).	0.00% 0/21 • Treatment and Follow-up periods (up to 42 weeks) All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).

Additional Information

Results Point of Contact* Name or Official Title Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
• Publication restrictions are in place

Restriction type: OTHER