Trial Outcomes & Findings for Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Genotype (GT)1 and GT2 Infection (MK-3682-011) (NCT NCT02332707)

Last Updated: 2019-07-23

Results Overview

The percentage of participants with Hepatitis C virus (HCV) ribonucleic acid (RNA) \< Lower Limit of Quantification (LLoQ) 12 weeks after completing treatment (i.e., SVR12) in each arm was determined. Plasma levels of HCV RNA levels were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 assay, which has a LLoQ of 15 IU/mL.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

443 participants

Primary outcome timeframe

Up to 28 weeks

Results posted on

2019-07-23

Participant Flow

This trial was conducted at 95 study sites in Asia, the European Union, and North America.

The "Number Started" row reflects the number of randomized participants who received study treatment. A total of 443 participants were randomized but 1 participant withdrew consent prior to receiving any study treatment.

Participant milestones

Participant milestones
Measure	A1: GT1 NC GZR+UPR+EBR (8 Weeks) In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.	A2: GT1 NC GZR+UPR+RZR (8 Weeks) In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.	A3: GT2 NC GZR+UPR+EBR (8 Weeks) In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A4: GT2 NC GZR+UPR+RZR (8 Weeks) In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.	A5: GT1 NC GZR+UPR+EBR (8 Weeks) In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A6: GT1 NC GZR+UPR+RZR (8 Weeks) In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.	A7: GT2 NC GZR+UPR+EBR (8 Weeks) In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A8: GT2 NC GZR+UPR+RZR (8 Weeks) In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.	B9: GT1 NC GZR+UPR+RZR (12 Weeks) In Part B, HCV GT1-infected NC participants took 2 fixed dose combination (FDC) tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.	B11: GT2 NC GZR+UPR+RZR (12 Weeks) In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B12: GT1 C GZR+UPR+RZR (8 Weeks) In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B13: GT1 C GZR+UPR+RZR (12 Weeks) In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B14: GT2 C GZR+UPR+RZR (12 Weeks) In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.	B16: GT2 C GZR+UPR+RZR (16 Weeks) In Part B, HCV GT2-infected C participants took 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.	B6: GT1 NC GZR+UPR+RZR (8 Weeks) In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B8: GT2 NC GZR+UPR+RZR (8 Weeks) In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.
Overall Study STARTED	23	24	16	14	23	23	15	16	48	31	31	35	40	15	16	26	30	16
Overall Study COMPLETED	23	24	15	13	23	22	15	16	48	28	29	35	35	15	16	26	30	16
Overall Study NOT COMPLETED	0	0	1	1	0	1	0	0	0	3	2	0	5	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	A3: GT2 NC GZR+UPR+EBR (8 Weeks) In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A4: GT2 NC GZR+UPR+RZR (8 Weeks) In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.	A6: GT1 NC GZR+UPR+RZR (8 Weeks) In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.	B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.	B11: GT2 NC GZR+UPR+RZR (12 Weeks) In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B13: GT1 C GZR+UPR+RZR (12 Weeks) In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.
Overall Study Adverse Event	0	0	0	0	0	1
Overall Study Lost to Follow-up	0	0	1	0	2	3
Overall Study Physician Decision	0	1	0	0	0	1
Overall Study Withdrawal by Subject	1	0	0	3	0	0

Baseline Characteristics

Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Genotype (GT)1 and GT2 Infection (MK-3682-011)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A1: GT1 NC GZR+UPR+EBR (8 Weeks) n=23 Participants In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.	A2: GT1 NC GZR+UPR+RZR (8 Weeks) n=24 Participants In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.	A3: GT2 NC GZR+UPR+EBR (8 Weeks) n=16 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A4: GT2 NC GZR+UPR+RZR (8 Weeks) n=14 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.	A5: GT1 NC GZR+UPR+EBR (8 Weeks) n=23 Participants In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A6: GT1 NC GZR+UPR+RZR (8 Weeks) n=23 Participants In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.	A7: GT2 NC GZR+UPR+EBR (8 Weeks) n=15 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A8: GT2 NC GZR+UPR+RZR (8 Weeks) n=16 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.	B9: GT1 NC GZR+UPR+RZR (12 Weeks) n=48 Participants In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV n=31 Participants In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.	B11: GT2 NC GZR+UPR+RZR (12 Weeks) n=31 Participants In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B12: GT1 C GZR+UPR+RZR (8 Weeks) n=35 Participants In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B13: GT1 C GZR+UPR+RZR (12 Weeks) n=40 Participants In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B14: GT2 C GZR+UPR+RZR (12 Weeks) n=15 Participants In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV n=16 Participants In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.	B16: GT2 C GZR+UPR+RZR (16 Weeks) n=26 Participants In Part B, HCV GT2-infected C participants took 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.	B6: GT1 NC GZR+UPR+RVR (8 Weeks) n=30 Participants In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B8: GT2 NC GZR+UPR+RZR (8 Weeks) n=16 Participants In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	Total n=442 Participants Total of all reporting groups
Age, Continuous	50.2 Years STANDARD_DEVIATION 13.5 • n=5 Participants	45.0 Years STANDARD_DEVIATION 14.5 • n=7 Participants	49.4 Years STANDARD_DEVIATION 15.8 • n=5 Participants	52.6 Years STANDARD_DEVIATION 11.6 • n=4 Participants	49.0 Years STANDARD_DEVIATION 11.2 • n=21 Participants	46.7 Years STANDARD_DEVIATION 13.9 • n=10 Participants	52.9 Years STANDARD_DEVIATION 12.1 • n=115 Participants	48.3 Years STANDARD_DEVIATION 8.8 • n=24 Participants	48.8 Years STANDARD_DEVIATION 13.9 • n=42 Participants	49.8 Years STANDARD_DEVIATION 13.0 • n=42 Participants	55.6 Years STANDARD_DEVIATION 14.4 • n=42 Participants	58.8 Years STANDARD_DEVIATION 9.6 • n=42 Participants	56.9 Years STANDARD_DEVIATION 11.1 • n=36 Participants	61.8 Years STANDARD_DEVIATION 6.8 • n=36 Participants	59.8 Years STANDARD_DEVIATION 8.0 • n=24 Participants	64.0 Years STANDARD_DEVIATION 9.3 • n=135 Participants	47.4 Years STANDARD_DEVIATION 11.7 • n=136 Participants	51.4 Years STANDARD_DEVIATION 10.8 • n=44 Participants	52.6 Years STANDARD_DEVIATION 13.0 • n=667 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	13 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	14 Participants n=21 Participants	9 Participants n=10 Participants	9 Participants n=115 Participants	8 Participants n=24 Participants	21 Participants n=42 Participants	16 Participants n=42 Participants	16 Participants n=42 Participants	14 Participants n=42 Participants	11 Participants n=36 Participants	3 Participants n=36 Participants	4 Participants n=24 Participants	9 Participants n=135 Participants	14 Participants n=136 Participants	9 Participants n=44 Participants	192 Participants n=667 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	9 Participants n=21 Participants	14 Participants n=10 Participants	6 Participants n=115 Participants	8 Participants n=24 Participants	27 Participants n=42 Participants	15 Participants n=42 Participants	15 Participants n=42 Participants	21 Participants n=42 Participants	29 Participants n=36 Participants	12 Participants n=36 Participants	12 Participants n=24 Participants	17 Participants n=135 Participants	16 Participants n=136 Participants	7 Participants n=44 Participants	250 Participants n=667 Participants

PRIMARY outcome

Timeframe: Up to 28 weeks

Population: All randomized participants who received at least 1 dose of study drug and had SVR12 results available are included.

Outcome measures

Outcome measures
Measure	A1: GT1 NC GZR+UPR+EBR (8 Weeks) n=23 Participants In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.	A2: GT1 NC GZR+UPR+RZR (8 Weeks) n=24 Participants In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.	A3: GT2 NC GZR+UPR+EBR (8 Weeks) n=16 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A4: GT2 NC GZR+UPR+RZR (8 Weeks) n=14 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.	A5: GT1 NC GZR+UPR+EBR (8 Weeks) n=23 Participants In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A6: GT1 NC GZR+UPR+RZR (8 Weeks) n=23 Participants In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.	B6: GT1 NC GZR+UPR+RVR (8 Weeks) n=30 Participants In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	A7: GT2 NC GZR+UPR+EBR (8 Weeks) n=15 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A8: GT2 NC GZR+UPR+RZR (8 Weeks) n=16 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.	B8: GT2 NC GZR+UPR+RZR (8 Weeks) n=16 Participants In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B9: GT1 NC GZR+UPR+RZR (12 Weeks) n=48 Participants In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV n=30 Participants In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.	B11: GT2 NC GZR+UPR+RZR (12 Weeks) n=30 Participants In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B12: GT1 C GZR+UPR+RZR (8 Weeks) n=35 Participants In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B13: GT1 C GZR+UPR+RZR (12 Weeks) n=39 Participants In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B14: GT2 C GZR+UPR+RZR (12 Weeks) n=15 Participants In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV n=16 Participants In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.	16: GT2 C GZR+UPR+RZR (16 Weeks) n=25 Participants In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Treatment (SVR12)	100.0 Percentage of Participants Interval 85.2 to 100.0	100.0 Percentage of Participants Interval 85.8 to 100.0	68.8 Percentage of Participants Interval 41.3 to 89.0	71.4 Percentage of Participants Interval 41.9 to 91.6	100.0 Percentage of Participants Interval 85.2 to 100.0	91.3 Percentage of Participants Interval 72.0 to 98.9	100.0 Percentage of Participants Interval 88.4 to 100.0	60.0 Percentage of Participants Interval 32.3 to 83.7	93.8 Percentage of Participants Interval 69.8 to 99.8	87.5 Percentage of Participants Interval 61.7 to 98.4	100.0 Percentage of Participants Interval 92.6 to 100.0	83.3 Percentage of Participants Interval 65.3 to 94.4	100.0 Percentage of Participants Interval 88.4 to 100.0	97.1 Percentage of Participants Interval 85.1 to 99.9	100.0 Percentage of Participants Interval 91.0 to 100.0	100.0 Percentage of Participants Interval 78.2 to 100.0	100.0 Percentage of Participants Interval 79.4 to 100.0	100.0 Percentage of Participants Interval 86.3 to 100.0

PRIMARY outcome

Timeframe: Up to 18 weeks

Population: All randomized participants who received at least 1 dose of study drug are included.

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	A1: GT1 NC GZR+UPR+EBR (8 Weeks) n=23 Participants In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.	A2: GT1 NC GZR+UPR+RZR (8 Weeks) n=24 Participants In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.	A3: GT2 NC GZR+UPR+EBR (8 Weeks) n=16 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A4: GT2 NC GZR+UPR+RZR (8 Weeks) n=14 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.	A5: GT1 NC GZR+UPR+EBR (8 Weeks) n=23 Participants In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A6: GT1 NC GZR+UPR+RZR (8 Weeks) n=23 Participants In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.	B6: GT1 NC GZR+UPR+RVR (8 Weeks) n=30 Participants In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	A7: GT2 NC GZR+UPR+EBR (8 Weeks) n=15 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A8: GT2 NC GZR+UPR+RZR (8 Weeks) n=16 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.	B8: GT2 NC GZR+UPR+RZR (8 Weeks) n=16 Participants In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B9: GT1 NC GZR+UPR+RZR (12 Weeks) n=48 Participants In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV n=31 Participants In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.	B11: GT2 NC GZR+UPR+RZR (12 Weeks) n=31 Participants In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B12: GT1 C GZR+UPR+RZR (8 Weeks) n=35 Participants In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B13: GT1 C GZR+UPR+RZR (12 Weeks) n=40 Participants In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B14: GT2 C GZR+UPR+RZR (12 Weeks) n=15 Participants In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV n=16 Participants In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.	16: GT2 C GZR+UPR+RZR (16 Weeks) n=26 Participants In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
Percentage of Participants Experiencing an Adverse Event (AE)	60.9 Percentage of Participants	83.3 Percentage of Participants	56.3 Percentage of Participants	71.4 Percentage of Participants	73.9 Percentage of Participants	60.9 Percentage of Participants	62.3 Percentage of Participants	86.7 Percentage of Participants	75.0 Percentage of Participants	68.8 Percentage of Participants	72.9 Percentage of Participants	80.6 Percentage of Participants	71.0 Percentage of Participants	57.1 Percentage of Participants	72.5 Percentage of Participants	53.3 Percentage of Participants	81.3 Percentage of Participants	69.2 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 16 weeks

Population: All randomized participants who received at least 1 dose of study drug are included.

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	A1: GT1 NC GZR+UPR+EBR (8 Weeks) n=23 Participants In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.	A2: GT1 NC GZR+UPR+RZR (8 Weeks) n=24 Participants In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.	A3: GT2 NC GZR+UPR+EBR (8 Weeks) n=16 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A4: GT2 NC GZR+UPR+RZR (8 Weeks) n=14 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.	A5: GT1 NC GZR+UPR+EBR (8 Weeks) n=23 Participants In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A6: GT1 NC GZR+UPR+RZR (8 Weeks) n=23 Participants In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.	B6: GT1 NC GZR+UPR+RVR (8 Weeks) n=30 Participants In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	A7: GT2 NC GZR+UPR+EBR (8 Weeks) n=15 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A8: GT2 NC GZR+UPR+RZR (8 Weeks) n=16 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.	B8: GT2 NC GZR+UPR+RZR (8 Weeks) n=16 Participants In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B9: GT1 NC GZR+UPR+RZR (12 Weeks) n=48 Participants In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV n=31 Participants In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.	B11: GT2 NC GZR+UPR+RZR (12 Weeks) n=31 Participants In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B12: GT1 C GZR+UPR+RZR (8 Weeks) n=35 Participants In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B13: GT1 C GZR+UPR+RZR (12 Weeks) n=40 Participants In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B14: GT2 C GZR+UPR+RZR (12 Weeks) n=15 Participants In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV n=16 Participants In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.	16: GT2 C GZR+UPR+RZR (16 Weeks) n=26 Participants In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
Percentage of Participants Discontinuing From Study Treatment Due to an AE	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	6.5 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	2.5 Percentage of Participants	0 Percentage of Participants	12.5 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 40 weeks

Population: All randomized participants who received at least 1 dose of study drug and had SVR24 results available are included.

The percentage of participants with HCV RNA \< LLoQ 24 weeks after completing treatment (i.e., SVR24) in each arm was determined. Plasma levels of HCV RNA levels were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 assay, which has a LLoQ of 15 IU/mL.

Outcome measures

Outcome measures
Measure	A1: GT1 NC GZR+UPR+EBR (8 Weeks) n=23 Participants In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.	A2: GT1 NC GZR+UPR+RZR (8 Weeks) n=24 Participants In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.	A3: GT2 NC GZR+UPR+EBR (8 Weeks) n=16 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A4: GT2 NC GZR+UPR+RZR (8 Weeks) n=14 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.	A5: GT1 NC GZR+UPR+EBR (8 Weeks) n=23 Participants In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A6: GT1 NC GZR+UPR+RZR (8 Weeks) n=22 Participants In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.	B6: GT1 NC GZR+UPR+RVR (8 Weeks) n=30 Participants In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	A7: GT2 NC GZR+UPR+EBR (8 Weeks) n=15 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A8: GT2 NC GZR+UPR+RZR (8 Weeks) n=16 Participants In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.	B8: GT2 NC GZR+UPR+RZR (8 Weeks) n=16 Participants In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B9: GT1 NC GZR+UPR+RZR (12 Weeks) n=48 Participants In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV n=30 Participants In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.	B11: GT2 NC GZR+UPR+RZR (12 Weeks) n=29 Participants In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B12: GT1 C GZR+UPR+RZR (8 Weeks) n=35 Participants In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B13: GT1 C GZR+UPR+RZR (12 Weeks) n=35 Participants In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B14: GT2 C GZR+UPR+RZR (12 Weeks) n=15 Participants In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV n=16 Participants In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.	16: GT2 C GZR+UPR+RZR (16 Weeks) n=25 Participants In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24)	100.0 Percentage of Participants Interval 85.2 to 100.0	100.0 Percentage of Participants Interval 85.8 to 100.0	68.8 Percentage of Participants Interval 41.3 to 89.0	71.4 Percentage of Participants Interval 41.9 to 91.6	100.0 Percentage of Participants Interval 85.2 to 100.0	90.9 Percentage of Participants Interval 70.8 to 98.9	100.0 Percentage of Participants Interval 88.4 to 100.0	60.0 Percentage of Participants Interval 32.3 to 83.7	93.8 Percentage of Participants Interval 69.8 to 99.8	87.5 Percentage of Participants Interval 61.7 to 98.4	100.0 Percentage of Participants Interval 92.6 to 100.0	83.3 Percentage of Participants Interval 65.3 to 94.4	100.0 Percentage of Participants Interval 88.1 to 100.0	97.1 Percentage of Participants Interval 85.1 to 99.9	100.0 Percentage of Participants Interval 90.1 to 100.0	100.0 Percentage of Participants Interval 78.2 to 100.0	100.0 Percentage of Participants Interval 79.4 to 100.0	100.0 Percentage of Participants Interval 86.3 to 100.0

Adverse Events

A1: GT1 NC GZR+UPR+EBR (8 Weeks)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

A2: GT1 NC GZR+UPR+RZR (8 Weeks)

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

A3: GT2 NC GZR+UPR+EBR (8 Weeks)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

A4: GT2 NC GZR+UPR+RZR (8 Weeks)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

A5: GT1 NC GZR+UPR+EBR (8 Weeks)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

A6: GT1 NC GZR+UPR+RZR (8 Weeks)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

A7: GT2 NC GZR+UPR+EBR (8 Weeks)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

A8: GT2 NC GZR+UPR+RZR (8 Weeks)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

B6: GT1 NC GZR+UPR+RVR (8 Weeks)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

B8: GT2 NC GZR+UPR+RZR (8 Weeks)

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

B9: GT1 NC GZR+UPR+RZR (12 Weeks)

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBVMax 62 Characters...

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

B11: GT2 NC GZR+UPR+RZR (12 Weeks)

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

B12: GT1 C GZR+UPR+RZR (8 Weeks)

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

B13: GT1 C GZR+UPR+RZR (12 Weeks)

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

B14: GT2 C GZR+UPR+RZR (12 Weeks)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

B16: GT2 C GZR+UPR+RZR (16 Weeks)

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	A1: GT1 NC GZR+UPR+EBR (8 Weeks) n=23 participants at risk In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.	A2: GT1 NC GZR+UPR+RZR (8 Weeks) n=24 participants at risk In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.	A3: GT2 NC GZR+UPR+EBR (8 Weeks) n=16 participants at risk In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A4: GT2 NC GZR+UPR+RZR (8 Weeks) n=14 participants at risk In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.	A5: GT1 NC GZR+UPR+EBR (8 Weeks) n=23 participants at risk In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A6: GT1 NC GZR+UPR+RZR (8 Weeks) n=23 participants at risk In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.	A7: GT2 NC GZR+UPR+EBR (8 Weeks) n=15 participants at risk In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A8: GT2 NC GZR+UPR+RZR (8 Weeks) n=16 participants at risk In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.	B6: GT1 NC GZR+UPR+RVR (8 Weeks) n=30 participants at risk In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B8: GT2 NC GZR+UPR+RZR (8 Weeks) n=16 participants at risk In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B9: GT1 NC GZR+UPR+RZR (12 Weeks) n=48 participants at risk In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBVMax 62 Characters... n=31 participants at risk In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.	B11: GT2 NC GZR+UPR+RZR (12 Weeks) n=31 participants at risk In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B12: GT1 C GZR+UPR+RZR (8 Weeks) n=35 participants at risk In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B13: GT1 C GZR+UPR+RZR (12 Weeks) n=40 participants at risk In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B14: GT2 C GZR+UPR+RZR (12 Weeks) n=15 participants at risk In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV n=16 participants at risk In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.	B16: GT2 C GZR+UPR+RZR (16 Weeks) n=26 participants at risk In Part B, HCV GT2-infected C participants took 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
Cardiac disorders Atrial fibrillation	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Cardiac disorders Tachycardia	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Eye disorders Retinal artery occlusion	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Oesophagitis	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Pancreatitis	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Vomiting	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Device related infection	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Pilonidal cyst	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Pneumonia	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Septic shock	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Psychiatric disorders Depression	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.

Other adverse events

Other adverse events
Measure	A1: GT1 NC GZR+UPR+EBR (8 Weeks) n=23 participants at risk In Part A, Hepatitis C virus (HCV) genotype (GT)1-infected non-cirrhotic (NC) participants took grazoprevir (GZR) 100 mg + uprifosbuvir (UPR) 300 mg + elbasvir (EBR) 50 mg once daily (q.d.) by mouth for 8 weeks.	A2: GT1 NC GZR+UPR+RZR (8 Weeks) n=24 participants at risk In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 300 mg + ruzasvir (RZR) 60 mg q.d. by mouth for 8 weeks.	A3: GT2 NC GZR+UPR+EBR (8 Weeks) n=16 participants at risk In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A4: GT2 NC GZR+UPR+RZR (8 Weeks) n=14 participants at risk In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 300 mg + RZR 60 mg q.d. by mouth for 8 weeks.	A5: GT1 NC GZR+UPR+EBR (8 Weeks) n=23 participants at risk In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A6: GT1 NC GZR+UPR+RZR (8 Weeks) n=23 participants at risk In Part A, HCV GT1-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.	A7: GT2 NC GZR+UPR+EBR (8 Weeks) n=15 participants at risk In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + EBR 50 mg q.d. by mouth for 8 weeks.	A8: GT2 NC GZR+UPR+RZR (8 Weeks) n=16 participants at risk In Part A, HCV GT2-infected NC participants took GZR 100 mg + UPR 450 mg + RZR 60 mg q.d. by mouth for 8 weeks.	B6: GT1 NC GZR+UPR+RVR (8 Weeks) n=30 participants at risk In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B8: GT2 NC GZR+UPR+RZR (8 Weeks) n=16 participants at risk In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B9: GT1 NC GZR+UPR+RZR (12 Weeks) n=48 participants at risk In Part B, HCV GT1-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBVMax 62 Characters... n=31 participants at risk In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.	B11: GT2 NC GZR+UPR+RZR (12 Weeks) n=31 participants at risk In Part B, HCV GT2-infected NC participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B12: GT1 C GZR+UPR+RZR (8 Weeks) n=35 participants at risk In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 8 weeks.	B13: GT1 C GZR+UPR+RZR (12 Weeks) n=40 participants at risk In Part B, HCV GT1-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B14: GT2 C GZR+UPR+RZR (12 Weeks) n=15 participants at risk In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks.	B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV n=16 participants at risk In Part B, HCV GT2-infected C participants took 2 FDC tablets containing GZR 50 mg + UPR 225 mg + RZR 30 mg per tablet q.d. by mouth for 12 weeks. Participants will also take RBV b.i.d. at a total daily dose of 800-1600 mg based on body weight.	B16: GT2 C GZR+UPR+RZR (16 Weeks) n=26 participants at risk In Part B, HCV GT2-infected C participants took 2 FDC tablets containing UPR 225 mg + GZR 50 mg + RZR 30 mg per tablet q.d. by mouth for 16 weeks.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 2/48 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	5.0% 2/40 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Blood and lymphatic system disorders Anaemia	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Cardiac disorders Atrial fibrillation	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.7% 2/26 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Cardiac disorders Palpitations	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.7% 2/23 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Cardiac disorders Sinus bradycardia	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Ear and labyrinth disorders Excessive cerumen production	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Ear and labyrinth disorders Tinnitus	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Ear and labyrinth disorders Vertigo	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	5.0% 2/40 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Endocrine disorders Androgen deficiency	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Endocrine disorders Hypothyroidism	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Eye disorders Blepharospasm	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Abdominal discomfort	8.7% 2/23 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.3% 2/24 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Abdominal pain	8.7% 2/23 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.7% 2/23 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	11.5% 3/26 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	5.7% 2/35 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	15.4% 4/26 • Number of events 4 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Constipation	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	13.3% 2/15 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 2/30 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.5% 2/31 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Diarrhoea	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	17.4% 4/23 • Number of events 4 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	10.0% 3/30 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	10.4% 5/48 • Number of events 5 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.9% 4/31 • Number of events 4 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	13.3% 2/15 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Dry mouth	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.3% 2/24 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	10.0% 3/30 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 2/48 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.7% 2/26 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Dyspepsia	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	20.0% 3/15 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Flatulence	4.3% 1/23 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.3% 2/24 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.7% 2/23 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	20.0% 3/15 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 3/48 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.5% 2/31 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.7% 2/26 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Gastrointestinal disorder	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Gingival pain	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Nausea	8.7% 2/23 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 3/24 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	14.3% 2/14 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	13.0% 3/23 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	40.0% 6/15 • Number of events 8 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	18.8% 3/16 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	16.7% 5/30 • Number of events 5 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	14.6% 7/48 • Number of events 7 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	16.1% 5/31 • Number of events 6 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.5% 3/40 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	13.3% 2/15 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	18.8% 3/16 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	15.4% 4/26 • Number of events 4 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
General disorders Asthenia	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.3% 2/24 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	18.8% 3/16 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.7% 2/23 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	9.7% 3/31 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	18.8% 3/16 • Number of events 5 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Vomiting	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 2/30 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 2/48 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	18.8% 3/16 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.7% 2/26 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
General disorders Chills	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.3% 1/30 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.5% 2/31 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
General disorders Crying	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
General disorders Drug withdrawal syndrome	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
General disorders Energy increased	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
General disorders Fatigue	17.4% 4/23 • Number of events 5 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 3/24 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	14.3% 2/14 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	26.1% 6/23 • Number of events 6 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	17.4% 4/23 • Number of events 4 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	40.0% 6/15 • Number of events 6 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	37.5% 6/16 • Number of events 6 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	13.3% 4/30 • Number of events 4 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	18.8% 3/16 • Number of events 4 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	16.7% 8/48 • Number of events 9 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.9% 4/31 • Number of events 4 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.6% 3/35 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.5% 3/40 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	31.2% 5/16 • Number of events 5 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	11.5% 3/26 • Number of events 4 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
General disorders Feeling cold	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
General disorders Influenza like illness	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	5.0% 2/40 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
General disorders Oedema peripheral	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
General disorders Peripheral swelling	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
General disorders Pyrexia	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
General disorders Vessel puncture site reaction	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Hepatobiliary disorders Hepatic pain	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Bronchitis	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Cellulitis	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	5.0% 2/40 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Cystitis	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	5.7% 2/35 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Ear infection	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Gastroenteritis	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.5% 2/31 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Gingivitis	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.3% 1/30 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Influenza	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 3/48 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Nasopharyngitis	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	20.0% 3/15 • Number of events 4 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	18.8% 3/16 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	9.7% 3/31 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.5% 3/40 • Number of events 4 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Oral herpes	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Pneumonia	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Sialoadenitis	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Sinusitis	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Tooth abscess	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.3% 1/30 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Upper respiratory tract infection	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.3% 2/24 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 2/30 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	9.7% 3/31 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Infections and infestations Urinary tract infection	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.3% 1/30 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 2/48 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.5% 2/31 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Injury, poisoning and procedural complications Contusion	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Injury, poisoning and procedural complications Sunburn	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Investigations Aspartate aminotransferase increased	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Investigations Blood creatine phosphokinase increased	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.3% 1/30 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Investigations Blood potassium increased	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Investigations Electrocardiogram QT prolonged	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.3% 1/30 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Investigations Haemoglobin decreased	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	13.3% 2/15 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Investigations Lipase increased	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Investigations Liver function test increased	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Investigations Pulse abnormal	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Investigations Weight decreased	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Investigations Weight increased	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Metabolism and nutrition disorders Increased appetite	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	13.0% 3/23 • Number of events 4 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 2/30 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	18.8% 3/16 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	9.7% 3/31 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.5% 3/40 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.7% 2/26 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Musculoskeletal and connective tissue disorders Back pain	8.7% 2/23 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.3% 2/24 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	18.8% 3/16 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.3% 1/30 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	5.0% 2/40 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	20.0% 3/15 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 2/48 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.5% 2/31 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	5.0% 2/40 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Nervous system disorders Disturbance in attention	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Nervous system disorders Dizziness	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	17.4% 4/23 • Number of events 5 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	26.7% 4/15 • Number of events 5 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.3% 1/30 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 4 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Nervous system disorders Dysgeusia	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.7% 2/23 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.3% 1/30 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.5% 2/31 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Nervous system disorders Headache	13.0% 3/23 • Number of events 5 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	29.2% 7/24 • Number of events 9 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	18.8% 3/16 • Number of events 4 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	14.3% 2/14 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	34.8% 8/23 • Number of events 9 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	13.0% 3/23 • Number of events 4 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	33.3% 5/15 • Number of events 5 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	56.2% 9/16 • Number of events 10 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 2/30 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	18.8% 3/16 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	31.2% 15/48 • Number of events 25 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	25.8% 8/31 • Number of events 8 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	22.6% 7/31 • Number of events 7 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	14.3% 5/35 • Number of events 6 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 5/40 • Number of events 11 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	13.3% 2/15 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	15.4% 4/26 • Number of events 10 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Nervous system disorders Hypoaesthesia	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Nervous system disorders Lethargy	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	14.3% 2/14 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Nervous system disorders Paraesthesia	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Nervous system disorders Syncope	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Psychiatric disorders Affective disorder	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Psychiatric disorders Anxiety	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 2/48 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.5% 2/31 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Psychiatric disorders Depression	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	13.3% 2/15 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 2/48 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.5% 2/31 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.5% 2/31 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Psychiatric disorders Flat affect	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Psychiatric disorders Initial insomnia	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Psychiatric disorders Insomnia	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	14.3% 2/14 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	13.3% 2/15 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	10.0% 3/30 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.3% 4/48 • Number of events 5 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.9% 4/31 • Number of events 4 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.5% 2/31 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.5% 3/40 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Psychiatric disorders Irritability	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.5% 2/31 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Psychiatric disorders Libido decreased	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.3% 1/30 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Psychiatric disorders Mood altered	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Psychiatric disorders Sleep disorder	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.3% 1/30 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Renal and urinary disorders Pollakiuria	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Renal and urinary disorders Renal pain	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Reproductive system and breast disorders Menstruation delayed	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.3% 1/30 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 3/48 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.9% 4/31 • Number of events 5 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.7% 2/26 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	13.3% 2/15 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.3% 1/30 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 2/48 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	5.0% 2/40 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Skin and subcutaneous tissue disorders Erythema	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.5% 2/31 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Skin and subcutaneous tissue disorders Alopecia	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	13.3% 2/15 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	9.7% 3/31 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 2/48 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.5% 2/31 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Skin and subcutaneous tissue disorders Macule	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.7% 2/23 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	20.0% 3/15 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	16.1% 5/31 • Number of events 5 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.3% 1/30 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Skin and subcutaneous tissue disorders Rash	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.3% 2/24 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	9.7% 3/31 • Number of events 5 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Vascular disorders Hot flush	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.3% 2/24 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	7.1% 1/14 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.7% 2/23 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 2/48 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Vascular disorders Hypertension	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 2/48 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	8.6% 3/35 • Number of events 3 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	5.0% 2/40 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Vascular disorders Orthostatic hypotension	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.7% 1/15 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	10.0% 3/30 • Number of events 4 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Eye disorders Vision blurred	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Abdominal distension	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.2% 1/24 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	4.3% 1/23 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.1% 1/48 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.2% 1/31 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.8% 1/26 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.9% 1/35 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Investigations Heart rate decreased	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/30 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	12.5% 2/16 • Number of events 2 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	2.5% 1/40 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.
Vascular disorders Essential hypertension	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/24 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/14 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/23 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	3.3% 1/30 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	6.2% 1/16 • Number of events 1 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/48 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/31 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/35 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/40 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/15 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/16 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.	0.00% 0/26 • Up to 18 weeks (14 days after completing treatment) All participants who received at least 1 dose of study drug are included.

Additional Information

Senior VIce President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

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.
Publication restrictions are in place

Restriction type: OTHER