Trial Outcomes & Findings for This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is (NCT NCT03635099)

Last Updated: 2022-08-03

Results Overview

Number of patients who achieved Psoriasis Area Severity Index score (PASI) 75 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease. PASI 75 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 75% reduction. No statistical comparisons were planned or carried out for Part 2 of the trial.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

274 participants

Primary outcome timeframe

Assesment at week 12 of treatment

Results posted on

2022-08-03

Participant Flow

This trial was a 2-part, randomised, placebo-controlled, double-blind, parallel-group, dose-ranging trial to investigate the efficacy, safety, and tolerability of different dose regimens of BI 730357 in patients with moderate-to-severe plaque psoriasis.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	Part I - Placebo (Fasted) Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 25 mg (Fasted) Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 50 mg (Fasted) Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 100 mg (Fasted) Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 200 mg (Fasted) Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Part II - Placebo (Fed) Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 400 mg Once Daily (Fed) Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 200 mg Twice Daily, 400 mg Total (Fed) Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Period 1 STARTED	20	40	39	39	40	10	44	42
Period 1 Full Analysis Set (FAS)	20	40	39	39	40	10	43	42
Period 1 COMPLETED	16	37	31	34	37	9	40	40
Period 1 NOT COMPLETED	4	3	8	5	3	1	4	2
Not Eligible for Period 2 STARTED	16	37	31	34	37	9	40	40
Not Eligible for Period 2 COMPLETED	15	37	31	33	37	0	0	0
Not Eligible for Period 2 NOT COMPLETED	1	0	0	1	0	9	40	40
Eligible for Period 2 STARTED	15	37	31	33	37	0	0	0
Eligible for Period 2 Switching Patients	15	35	21	25	0	0	0	0
Eligible for Period 2 Non Switching Patients	0	2	10	8	37	0	0	0
Eligible for Period 2 COMPLETED	0	2	10	8	37	0	0	0
Eligible for Period 2 NOT COMPLETED	15	35	21	25	0	0	0	0
Period 2 STARTED	0	2	45	29	77	0	0	0
Period 2 COMPLETED	0	2	36	25	65	0	0	0
Period 2 NOT COMPLETED	0	0	9	4	12	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part I - Placebo (Fasted) Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 25 mg (Fasted) Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 50 mg (Fasted) Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 100 mg (Fasted) Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 200 mg (Fasted) Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Part II - Placebo (Fed) Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 400 mg Once Daily (Fed) Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 200 mg Twice Daily, 400 mg Total (Fed) Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Period 1 Adverse Event	1	0	0	1	0	0	0	0
Period 1 Protocol Violation	0	0	1	0	0	0	0	0
Period 1 Lost to Follow-up	0	0	1	2	1	0	1	2
Period 1 Withdrawal by Subject	3	3	5	2	2	0	3	0
Period 1 History of suicidal ideation	0	0	1	0	0	0	0	0
Period 1 pursue other treatment options	0	0	0	0	0	1	0	0
Not Eligible for Period 2 Pregnancy	0	0	0	1	0	0	0	0
Not Eligible for Period 2 Withdrawal by Subject	1	0	0	0	0	0	0	0
Not Eligible for Period 2 Part II subjects did not have a period 2.	0	0	0	0	0	9	40	40
Eligible for Period 2 Switch to higher dose at end of period 1	15	35	21	25	0	0	0	0
Period 2 Adverse Event	0	0	1	0	1	0	0	0
Period 2 Lost to Follow-up	0	0	1	0	4	0	0	0
Period 2 Withdrawal by Subject	0	0	7	4	7	0	0	0

Baseline Characteristics

This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part I - Placebo (Fasted) n=20 Participants Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 25 mg (Fasted) n=40 Participants Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 50 mg (Fasted) n=39 Participants Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 100 mg (Fasted) n=39 Participants Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 200 mg (Fasted) n=40 Participants Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Part II - Placebo (Fed) n=10 Participants Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 400 mg Once Daily (Fed) n=43 Participants Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 200 mg Twice Daily, 400 mg Total (Fed) n=42 Participants Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.	Total n=273 Participants Total of all reporting groups
Age, Continuous	48.1 years STANDARD_DEVIATION 14.7 • n=5 Participants	47.2 years STANDARD_DEVIATION 13.7 • n=7 Participants	46.3 years STANDARD_DEVIATION 15.1 • n=5 Participants	47.6 years STANDARD_DEVIATION 14.4 • n=4 Participants	43.8 years STANDARD_DEVIATION 13.1 • n=21 Participants	51.6 years STANDARD_DEVIATION 16.3 • n=8 Participants	44.1 years STANDARD_DEVIATION 14.7 • n=8 Participants	43.7 years STANDARD_DEVIATION 11.5 • n=24 Participants	45.8 years STANDARD_DEVIATION 13.9 • n=42 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	12 Participants n=4 Participants	14 Participants n=21 Participants	3 Participants n=8 Participants	6 Participants n=8 Participants	16 Participants n=24 Participants	84 Participants n=42 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	27 Participants n=4 Participants	26 Participants n=21 Participants	7 Participants n=8 Participants	37 Participants n=8 Participants	26 Participants n=24 Participants	189 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	10 Participants n=4 Participants	7 Participants n=21 Participants	2 Participants n=8 Participants	11 Participants n=8 Participants	11 Participants n=24 Participants	62 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	31 Participants n=7 Participants	31 Participants n=5 Participants	29 Participants n=4 Participants	33 Participants n=21 Participants	8 Participants n=8 Participants	32 Participants n=8 Participants	31 Participants n=24 Participants	211 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	5 Participants n=8 Participants	4 Participants n=24 Participants	20 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	5 Participants n=8 Participants	4 Participants n=24 Participants	20 Participants n=42 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	37 Participants n=7 Participants	33 Participants n=5 Participants	34 Participants n=4 Participants	37 Participants n=21 Participants	7 Participants n=8 Participants	33 Participants n=8 Participants	33 Participants n=24 Participants	230 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants
Psoriasis Area Severity Index score (PASI)	17.1 Score on scale STANDARD_DEVIATION 5.2 • n=5 Participants	17.4 Score on scale STANDARD_DEVIATION 6.2 • n=7 Participants	18.3 Score on scale STANDARD_DEVIATION 4.8 • n=5 Participants	18.6 Score on scale STANDARD_DEVIATION 6.0 • n=4 Participants	16.8 Score on scale STANDARD_DEVIATION 6.6 • n=21 Participants	17.8 Score on scale STANDARD_DEVIATION 5.4 • n=8 Participants	18.8 Score on scale STANDARD_DEVIATION 7.1 • n=8 Participants	17.9 Score on scale STANDARD_DEVIATION 7.4 • n=24 Participants	17.9 Score on scale STANDARD_DEVIATION 6.3 • n=42 Participants
Static Physician's Global Assessment score (sPGA) Moderate	16 Participants n=5 Participants	35 Participants n=7 Participants	29 Participants n=5 Participants	34 Participants n=4 Participants	30 Participants n=21 Participants	7 Participants n=8 Participants	34 Participants n=8 Participants	34 Participants n=24 Participants	219 Participants n=42 Participants
Static Physician's Global Assessment score (sPGA) Severe	4 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants	5 Participants n=4 Participants	10 Participants n=21 Participants	3 Participants n=8 Participants	9 Participants n=8 Participants	8 Participants n=24 Participants	54 Participants n=42 Participants

PRIMARY outcome

Timeframe: Assesment at week 12 of treatment

Population: Full Analysis Set (FAS): The FAS includes all patients who received at least 1 dose of trial medication and provided baseline and at least 1 post-randomisation measurement of Psoriasis Area Severity Index (PASI). Subjects with missing data for subsequent visits were included but those entries were imputed as failures.

Outcome measures

Outcome measures
Measure	Part I - Placebo (Fasted) n=20 Participants Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 25 mg (Fasted) n=40 Participants Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 50 mg (Fasted) n=39 Participants Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 100 mg (Fasted) n=39 Participants Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 200 mg (Fasted) n=40 Participants Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Part II - Placebo (Fed) n=10 Participants Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 400 mg Once Daily (Fed) n=43 Participants Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 200 mg Twice Daily, 400 mg Total (Fed) n=42 Participants Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Week 12	0 Participants	2 Participants	3 Participants	4 Participants	12 Participants	0 Participants	11 Participants	10 Participants

PRIMARY outcome

Timeframe: Assesment at week 12 of treatment

Number of patients who achieved a static Physician's Global Assessment score of 'clear' or 'almost clear' (sPGA 0/1) at Week 12. The sPGA used in this trial is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the subject's previous disease states, whether at Baseline or at a previous visit. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear. No statistical comparisons were planned or carried out for Part 2 of the trial.

Outcome measures

Outcome measures
Measure	Part I - Placebo (Fasted) n=20 Participants Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 25 mg (Fasted) n=40 Participants Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 50 mg (Fasted) n=39 Participants Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 100 mg (Fasted) n=39 Participants Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 200 mg (Fasted) n=40 Participants Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Part II - Placebo (Fed) n=10 Participants Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 400 mg Once Daily (Fed) n=43 Participants Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 200 mg Twice Daily, 400 mg Total (Fed) n=42 Participants Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Week 12.	0 Participants	1 Participants	3 Participants	2 Participants	11 Participants	0 Participants	11 Participants	10 Participants

SECONDARY outcome

Timeframe: Assesment at week 12 of treatment

Number of patients who achieved Psoriasis Area Severity Index score (PASI) 50 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease. PASI 50 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 50% reduction. No hypothesis testing was planned or carried out for Part II.

Outcome measures

Outcome measures
Measure	Part I - Placebo (Fasted) n=20 Participants Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 25 mg (Fasted) n=40 Participants Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 50 mg (Fasted) n=39 Participants Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 100 mg (Fasted) n=39 Participants Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 200 mg (Fasted) n=40 Participants Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Part II - Placebo (Fed) n=10 Participants Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 400 mg Once Daily (Fed) n=43 Participants Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 200 mg Twice Daily, 400 mg Total (Fed) n=42 Participants Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 50 at Week 12	1 Participants	2 Participants	10 Participants	8 Participants	20 Participants	1 Participants	24 Participants	19 Participants

SECONDARY outcome

Timeframe: Assesment at week 12 of treatment

Number of patients who achieved Psoriasis Area Severity Index score (PASI) 90 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease. PASI 90 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction. No statistical comparisons were planned or carried out for Part 2 of the trial. Statistical analysis could not be performed for arms with 0 participants reaching PASI 90.

Outcome measures

Outcome measures
Measure	Part I - Placebo (Fasted) n=20 Participants Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 25 mg (Fasted) n=40 Participants Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 50 mg (Fasted) n=39 Participants Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 100 mg (Fasted) n=39 Participants Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 200 mg (Fasted) n=40 Participants Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Part II - Placebo (Fed) n=10 Participants Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 400 mg Once Daily (Fed) n=43 Participants Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 200 mg Twice Daily, 400 mg Total (Fed) n=42 Participants Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 90 at Week 12	0 Participants	0 Participants	2 Participants	1 Participants	7 Participants	0 Participants	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Assesment at week 12 of treatment

Number of patients who achieved Psoriasis Area Severity Index score (PASI) 100 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease. PASI 100 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 100% reduction. No statistical comparisons were planned or carried out for Part 2 of the trial. Statistical analysis could not be performed for arms with 0 participants reaching PASI 100.

Outcome measures

Outcome measures
Measure	Part I - Placebo (Fasted) n=20 Participants Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 25 mg (Fasted) n=40 Participants Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 50 mg (Fasted) n=39 Participants Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 100 mg (Fasted) n=39 Participants Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 200 mg (Fasted) n=40 Participants Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Part II - Placebo (Fed) n=10 Participants Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 400 mg Once Daily (Fed) n=43 Participants Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 200 mg Twice Daily, 400 mg Total (Fed) n=42 Participants Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 100 at Week 12	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Assesment at week 16, 20 and 24 of treatment

Number of patients who achieved Psoriasis Area Severity Index score (PASI) 75 at weeks 16, 20 and 24. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease. PASI 75 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 75% reduction.

Outcome measures

Outcome measures
Measure	Part I - Placebo (Fasted) n=20 Participants Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 25 mg (Fasted) n=40 Participants Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 50 mg (Fasted) n=39 Participants Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 100 mg (Fasted) n=39 Participants Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 200 mg (Fasted) n=40 Participants Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Part II - Placebo (Fed) Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 400 mg Once Daily (Fed) Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 200 mg Twice Daily, 400 mg Total (Fed) Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Weeks 16, 20, and 24 Week 16	0 Participants	1 Participants	1 Participants	5 Participants	11 Participants	—	—	—
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Weeks 16, 20, and 24 Week 20	0 Participants	2 Participants	3 Participants	4 Participants	13 Participants	—	—	—
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Weeks 16, 20, and 24 Week 24	0 Participants	2 Participants	4 Participants	4 Participants	14 Participants	—	—	—

SECONDARY outcome

Timeframe: Assesment at week 12 of treatment

Number of patients who achieved a static Physician's Global Assessment score of 'clear' (sPGA 0) at Week 12. The sPGA used in this trial is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the subject's previous disease states, whether at Baseline or at a previous visit. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear. No statistical comparisons were planned or carried out for Part 2 of the trial.

Outcome measures

Outcome measures
Measure	Part I - Placebo (Fasted) n=20 Participants Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 25 mg (Fasted) n=40 Participants Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 50 mg (Fasted) n=39 Participants Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 100 mg (Fasted) n=39 Participants Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 200 mg (Fasted) n=40 Participants Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Part II - Placebo (Fed) n=10 Participants Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 400 mg Once Daily (Fed) n=43 Participants Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 200 mg Twice Daily, 400 mg Total (Fed) n=42 Participants Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' (sPGA 0) at Week 12	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Assesment at week 16, 20 and 24 of treatment

Number of patients who achieved a static Physician's Global Assessment score of 'clear' or 'almost clear' (sPGA 0/1) at Week 16, 20 and 24. The sPGA used in this trial is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the subject's previous disease states, whether at Baseline or at a previous visit. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.

Outcome measures

Outcome measures
Measure	Part I - Placebo (Fasted) n=20 Participants Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 25 mg (Fasted) n=40 Participants Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 50 mg (Fasted) n=39 Participants Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 100 mg (Fasted) n=39 Participants Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 200 mg (Fasted) n=40 Participants Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Part II - Placebo (Fed) Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 400 mg Once Daily (Fed) Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 200 mg Twice Daily, 400 mg Total (Fed) Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Weeks 16, 20, and 24 Week 24	0 Participants	1 Participants	3 Participants	4 Participants	13 Participants	—	—	—
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Weeks 16, 20, and 24 Week 16	0 Participants	1 Participants	2 Participants	3 Participants	12 Participants	—	—	—
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Weeks 16, 20, and 24 Week 20	0 Participants	1 Participants	4 Participants	2 Participants	10 Participants	—	—	—

SECONDARY outcome

Timeframe: Assesment at week 12 of treatment

Population: Full Analysis Set (FAS): All patients who received at least 1 dose of trial medication and provided a baseline and at least 1 postrandomisation measurement of PASI. Only participants with non-missing values are reported.

Overall change from baseline in psoriasis symptoms evaluated using the total score of the Psoriasis Symptoms Scale (PSS) at Week 12. The PSS is a four-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis. The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed for a 24 hour recall period using a 5-point verbal rating scale, the PSS score ranges from 0 (none) to 4 (very severe). The symptom scores are added to an unweighted total score (range: 0 to 16). Presented 'Mean' values are actually 'Adjusted Mean'. No hypothesis testing was planned or carried out for Part II.

Outcome measures

Outcome measures
Measure	Part I - Placebo (Fasted) n=20 Participants Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 25 mg (Fasted) n=40 Participants Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 50 mg (Fasted) n=38 Participants Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 100 mg (Fasted) n=38 Participants Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 200 mg (Fasted) n=40 Participants Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Part II - Placebo (Fed) n=10 Participants Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 400 mg Once Daily (Fed) n=43 Participants Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 200 mg Twice Daily, 400 mg Total (Fed) n=42 Participants Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Overall Change From Baseline in Psoriasis Symptoms Evaluated Using the Total Score of the Psoriasis Symptoms Scale (PSS) at Week 12	-0.4 Total score Standard Error 1.0	0.1 Total score Standard Error 0.7	0.2 Total score Standard Error 0.7	2.3 Total score Standard Error 0.7	3.6 Total score Standard Error 0.7	0.3 Total score Standard Error 1.2	3.4 Total score Standard Error 0.6	3.3 Total score Standard Error 0.6

SECONDARY outcome

Timeframe: Assesment at week 12 of treatment

Population: Full Analysis Set (FAS): All patients who received at least 1 dose of trial medication and provided a baseline and at least 1 postrandomisation measurement of PASI. Subjects with missing data for subsequent visits were included but those entries were imputed as failures.

Number of patients who achieved a Dermatology Life Quality Index score of 'no effect on patient's life' (DLQI 0/1) at Week 12. The DLQI is a subject-administered, ten-question, quality of life questionnaire covering 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Item scores range from 0 (not relevant/not at all) to 3 (very much). Question 7 is a "yes"/ "no" question where "yes" is scored as 3. DLQI total score is calculated by summing the scores of each question resulting in a range of 0 to 30 where 0-1 = no effect on subject's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on subject's life. The higher the score, the more the quality of life is impaired. A 4-point change from baseline is considered a clinically important difference. No hypothesis testing was planned or carried out for Part II.

Outcome measures

Outcome measures
Measure	Part I - Placebo (Fasted) n=20 Participants Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 25 mg (Fasted) n=40 Participants Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 50 mg (Fasted) n=39 Participants Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 100 mg (Fasted) n=39 Participants Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.	Part I - BI 200 mg (Fasted) n=40 Participants Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).	Part II - Placebo (Fed) n=10 Participants Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 400 mg Once Daily (Fed) n=43 Participants Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 200 mg Twice Daily, 400 mg Total (Fed) n=42 Participants Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Number of Patients Who Achieved a Dermatology Life Quality Index Score of 'no Effect on Patient's Life' (DLQI 0/1) at Week 12	1 Participants	3 Participants	3 Participants	3 Participants	8 Participants	2 Participants	12 Participants	11 Participants

Adverse Events

Part I - Period 1 - Fasted: Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part I - Period 1 - Fasted: BI 25 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part I - Period 1 - Fasted: BI 50 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part I - Period 1 - Fasted: BI 100 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part I - Period 1 - Fasted: BI 200 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part I - Period 1 and 2 - Fasted: Placebo - BI 200 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Part I - Period 1 and 2 - Fasted: BI 25 mg - BI 25 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part I - Period 1 and 2 - Fasted: BI 25 mg - BI 50 mg

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Part I - Period 1 and 2 - Fasted: BI 50 mg - BI 50 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part I - Period 1 and 2 - Fasted: BI 50 mg - BI 100 mg

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Part I - Period 1 and 2 - Fasted: BI 100 mg - BI 100 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part I - Period 1 and 2 - Fasted: BI 100 mg - BI 200 mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Part I - Period 1 and 2 - Fasted: BI 200 mg - BI 200 mg

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Part II - Placebo (Fed)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part II - BI 400 mg Once Daily (Fed)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part I - Period 1 - Fasted: Placebo n=5 participants at risk Part I - Period 1 - fasted: Placebo matching BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.	Part I - Period 1 - Fasted: BI 25 mg n=3 participants at risk Part I - Period 1 - fasted: 25 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.	Part I - Period 1 - Fasted: BI 50 mg n=8 participants at risk Part I - Period 1 - fasted: 50 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.	Part I - Period 1 - Fasted: BI 100 mg n=6 participants at risk Part I - Period 1 - fasted: 100 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.	Part I - Period 1 - Fasted: BI 200 mg n=3 participants at risk Part I - Period 1 - fasted: 200 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.	Part I - Period 1 and 2 - Fasted: Placebo - BI 200 mg n=15 participants at risk Part I - Period 1 and 2 - fasted: Placebo participants in period who failed to achieve a PASI 75 response at Week 12 and were switched to a 200 mg dose in period 2.	Part I - Period 1 and 2 - Fasted: BI 25 mg - BI 25 mg n=2 participants at risk Part I - Period 1 and 2 - fasted: 25 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted in period 1. Participants who achieved a PASI 50 response at Week 12 and stayed on a 25 mg dose in period 2.	Part I - Period 1 and 2 - Fasted: BI 25 mg - BI 50 mg n=35 participants at risk Part I - Period 1 and 2 - fasted: Participants assigned 25 milligram (mg) BI 730357 in period 1 (taken orally daily as a film-coated tablet in the morning while fasted) who failed to achieve a PASI 50 response at Week 12 and were switched to a 50 mg dose in period 2.	Part I - Period 1 and 2 - Fasted: BI 50 mg - BI 50 mg n=10 participants at risk Part I - Period 1 and 2 - fasted: 50 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted in period 1. Participants who achieved a PASI 50 response at Week 12 and stayed on a 50 mg dose in period 2.	Part I - Period 1 and 2 - Fasted: BI 50 mg - BI 100 mg n=21 participants at risk Part I - Period 1 and 2 - fasted: Participants assigned 50 milligram (mg) BI 730357 in period 1 (taken orally daily as a film-coated tablet in the morning while fasted) who failed to achieve a PASI 50 response at Week 12 and were switched to a 100 mg dose in period 2.	Part I - Period 1 and 2 - Fasted: BI 100 mg - BI 100 mg n=8 participants at risk Part I - Period 1 and 2 - fasted: 100 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted in period 1. Participants who achieved a PASI 50 response at Week 12 and stayed on a 100 mg dose in period 2.	Part I - Period 1 and 2 - Fasted: BI 100 mg - BI 200 mg n=25 participants at risk Part I - Period 1 and 2 - fasted: Participants assigned 100 milligram (mg) BI 730357 in period 1 (taken orally daily as a film-coated tablet in the morning while fasted) who failed to achieve a PASI 50 response at Week 12 and were switched to a 200 mg dose in period 2.	Part I - Period 1 and 2 - Fasted: BI 200 mg - BI 200 mg n=37 participants at risk Part I - Period 1 and 2 - fasted: Participants assigned 200 milligram (mg) BI 730357 in period 1 (taken orally daily as a film-coated tablet in the morning while fasted) who remained on the 200 mg throughout period 1 and 2.	Part II - Placebo (Fed) n=10 participants at risk Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 400 mg Once Daily (Fed) n=44 participants at risk Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 200 mg Twice Daily, 400 mg Total (Fed) n=42 participants at risk Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	4.8% 1/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.9% 1/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.9% 1/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.

Other adverse events

Other adverse events
Measure	Part I - Period 1 - Fasted: Placebo n=5 participants at risk Part I - Period 1 - fasted: Placebo matching BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.	Part I - Period 1 - Fasted: BI 25 mg n=3 participants at risk Part I - Period 1 - fasted: 25 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.	Part I - Period 1 - Fasted: BI 50 mg n=8 participants at risk Part I - Period 1 - fasted: 50 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.	Part I - Period 1 - Fasted: BI 100 mg n=6 participants at risk Part I - Period 1 - fasted: 100 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.	Part I - Period 1 - Fasted: BI 200 mg n=3 participants at risk Part I - Period 1 - fasted: 200 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.	Part I - Period 1 and 2 - Fasted: Placebo - BI 200 mg n=15 participants at risk Part I - Period 1 and 2 - fasted: Placebo participants in period who failed to achieve a PASI 75 response at Week 12 and were switched to a 200 mg dose in period 2.	Part I - Period 1 and 2 - Fasted: BI 25 mg - BI 25 mg n=2 participants at risk Part I - Period 1 and 2 - fasted: 25 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted in period 1. Participants who achieved a PASI 50 response at Week 12 and stayed on a 25 mg dose in period 2.	Part I - Period 1 and 2 - Fasted: BI 25 mg - BI 50 mg n=35 participants at risk Part I - Period 1 and 2 - fasted: Participants assigned 25 milligram (mg) BI 730357 in period 1 (taken orally daily as a film-coated tablet in the morning while fasted) who failed to achieve a PASI 50 response at Week 12 and were switched to a 50 mg dose in period 2.	Part I - Period 1 and 2 - Fasted: BI 50 mg - BI 50 mg n=10 participants at risk Part I - Period 1 and 2 - fasted: 50 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted in period 1. Participants who achieved a PASI 50 response at Week 12 and stayed on a 50 mg dose in period 2.	Part I - Period 1 and 2 - Fasted: BI 50 mg - BI 100 mg n=21 participants at risk Part I - Period 1 and 2 - fasted: Participants assigned 50 milligram (mg) BI 730357 in period 1 (taken orally daily as a film-coated tablet in the morning while fasted) who failed to achieve a PASI 50 response at Week 12 and were switched to a 100 mg dose in period 2.	Part I - Period 1 and 2 - Fasted: BI 100 mg - BI 100 mg n=8 participants at risk Part I - Period 1 and 2 - fasted: 100 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted in period 1. Participants who achieved a PASI 50 response at Week 12 and stayed on a 100 mg dose in period 2.	Part I - Period 1 and 2 - Fasted: BI 100 mg - BI 200 mg n=25 participants at risk Part I - Period 1 and 2 - fasted: Participants assigned 100 milligram (mg) BI 730357 in period 1 (taken orally daily as a film-coated tablet in the morning while fasted) who failed to achieve a PASI 50 response at Week 12 and were switched to a 200 mg dose in period 2.	Part I - Period 1 and 2 - Fasted: BI 200 mg - BI 200 mg n=37 participants at risk Part I - Period 1 and 2 - fasted: Participants assigned 200 milligram (mg) BI 730357 in period 1 (taken orally daily as a film-coated tablet in the morning while fasted) who remained on the 200 mg throughout period 1 and 2.	Part II - Placebo (Fed) n=10 participants at risk Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 400 mg Once Daily (Fed) n=44 participants at risk Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.	Part II - BI 200 mg Twice Daily, 400 mg Total (Fed) n=42 participants at risk Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	33.3% 1/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Blood and lymphatic system disorders Lymphadenopathy	20.0% 1/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Ear and labyrinth disorders Hypoacusis	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	33.3% 1/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	33.3% 1/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Eye disorders Photophobia	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	33.3% 1/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Eye disorders Visual impairment	20.0% 1/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	33.3% 1/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.4% 1/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Gastrointestinal disorders Constipation	20.0% 1/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.7% 1/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Gastrointestinal disorders Diarrhoea	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	4.8% 1/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	4.0% 1/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.7% 1/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.4% 1/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Gastrointestinal disorders Food poisoning	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	10.0% 1/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Gastrointestinal disorders Nausea	20.0% 1/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.9% 1/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	8.0% 2/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.3% 1/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	7.1% 3/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Gastrointestinal disorders Toothache	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	6.7% 1/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	4.8% 1/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Gastrointestinal disorders Vomiting	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	33.3% 1/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.7% 1/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.3% 1/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
General disorders Asthenia	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	33.3% 1/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Infections and infestations Bacteriuria	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	33.3% 1/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.7% 1/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Infections and infestations Bronchitis	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	4.8% 1/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	5.4% 2/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Infections and infestations Chlamydial infection	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	10.0% 1/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Infections and infestations Cystitis	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	33.3% 1/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Infections and infestations Fungal infection	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Infections and infestations Gingivitis	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	10.0% 1/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	50.0% 1/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.7% 1/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Infections and infestations Influenza	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	8.6% 3/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Infections and infestations Localised infection	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	10.0% 1/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Infections and infestations Lyme disease	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Infections and infestations Nasopharyngitis	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	33.3% 1/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	5.7% 2/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	10.0% 1/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	14.3% 3/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	8.0% 2/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	8.1% 3/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Infections and infestations Otitis media	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Infections and infestations Sinusitis	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	33.3% 1/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	4.8% 1/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	4.0% 1/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.3% 1/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	16.7% 1/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	20.0% 3/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	50.0% 1/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.9% 1/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	20.0% 2/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	19.0% 4/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	8.0% 2/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	18.9% 7/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Infections and infestations Urinary tract infection	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	6.7% 1/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.9% 1/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	10.0% 1/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	4.0% 1/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	5.4% 2/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	4.5% 2/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.9% 1/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	6.7% 1/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	4.0% 1/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Injury, poisoning and procedural complications Nail avulsion	20.0% 1/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	10.0% 1/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.4% 1/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	6.7% 1/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Investigations Alanine aminotransferase increased	20.0% 1/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	6.7% 1/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.4% 1/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Investigations Aspartate aminotransferase increased	20.0% 1/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.3% 1/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Investigations Blood creatine phosphokinase increased	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.4% 1/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Investigations Electrocardiogram ST segment depression	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	10.0% 1/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Investigations Gamma-glutamyltransferase increased	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	4.8% 1/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.7% 1/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.3% 1/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Investigations Liver function test increased	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	10.0% 1/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	4.0% 1/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	5.4% 2/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Investigations Occult blood positive	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Investigations Pancreatic enzymes increased	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Investigations Prothrombin time prolonged	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	6.7% 1/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	6.7% 1/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	9.5% 2/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	10.0% 1/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.3% 1/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.4% 1/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	6.7% 1/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Musculoskeletal and connective tissue disorders Muscle spasms	20.0% 1/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	4.8% 1/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	4.0% 1/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.7% 1/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	33.3% 1/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Nervous system disorders Dizziness	20.0% 1/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.9% 1/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.7% 1/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.3% 1/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Nervous system disorders Headache	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	33.3% 1/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	5.7% 2/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	9.5% 2/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.3% 1/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.4% 1/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Nervous system disorders Migraine	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Nervous system disorders Paraesthesia	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	50.0% 1/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.9% 1/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Psychiatric disorders Depression	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Psychiatric disorders Sleep disorder	20.0% 1/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Reproductive system and breast disorders Uterine spasm	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	33.3% 1/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	33.3% 1/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	10.0% 1/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	6.7% 1/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	33.3% 1/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	4.8% 1/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	4.0% 1/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.3% 1/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.4% 1/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Skin and subcutaneous tissue disorders Psoriasis	20.0% 1/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	33.3% 1/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	12.5% 1/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	13.3% 2/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	5.7% 2/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	10.0% 1/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.7% 1/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	6.7% 1/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Vascular disorders Hypertension	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	16.7% 1/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.9% 1/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	4.0% 1/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	5.4% 2/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	2.3% 1/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Cardiac disorders Defect conduction intraventricular	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	10.0% 1/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Eye disorders Cataract	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	10.0% 1/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Investigations Hepatic enzyme increased	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	10.0% 1/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
Renal and urinary disorders Renal failure	0.00% 0/5 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/6 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/3 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/15 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/2 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/35 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/21 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/8 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/25 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/37 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	10.0% 1/10 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/44 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.	0.00% 0/42 • Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II. Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.

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