Trial Outcomes & Findings for Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (NCT NCT01132313)

NCT ID: NCT01132313

Last Updated: 2016-02-01

Results Overview

Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) \<25IU/mL at Week 4 of treatment

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 488 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2016-02-01

Participant Flow

This trial was conducted in 4 parts, each consisting of randomised, open-label treatments.

Participant milestones

Measure	Part 1: 400mg DBV and 120mg FDV - 4w Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)	Part 1: 600mg DBV and 120mg FDV - 4w Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)	Part 2: 600mg DBV and 120mg FDV - 16w Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV TID and 120mg FDV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV - 40w Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 3: 600mg DBV and 120mg FDV - 16w Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 3: 800mg DBV and 120mg FDV - 24w Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 3: 600mg DBV and 120mg FDV - 24w Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 4: 600 mg DBV and 120mg FDV - 16w Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.	Part 4: 600 mg DBV and 120mg FDV - 24w Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
Overall Study STARTED	17	17	81	80	79	79	49	32	26	25	1	2
Overall Study COMPLETED	14	17	61	48	34	54	19	24	5	5	0	2
Overall Study NOT COMPLETED	3	0	20	32	45	25	30	8	21	20	1	0

Reasons for withdrawal

Measure	Part 1: 400mg DBV and 120mg FDV - 4w Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)	Part 1: 600mg DBV and 120mg FDV - 4w Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)	Part 2: 600mg DBV and 120mg FDV - 16w Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV TID and 120mg FDV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV - 40w Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 3: 600mg DBV and 120mg FDV - 16w Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 3: 800mg DBV and 120mg FDV - 24w Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 3: 600mg DBV and 120mg FDV - 24w Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 4: 600 mg DBV and 120mg FDV - 16w Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.	Part 4: 600 mg DBV and 120mg FDV - 24w Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
Overall Study Lack of Efficacy	1	0	0	0	0	0	0	3	14	16	0	0
Overall Study Not treated	2	0	0	0	2	1	3	0	0	0	0	0
Overall Study Adverse Event	0	0	4	10	19	6	5	3	7	2	0	0
Overall Study Protocol Violation	0	0	0	1	0	0	0	0	0	0	0	0
Overall Study Lost to Follow-up	0	0	1	0	0	0	0	1	0	0	0	0
Overall Study Withdrawal by Subject	0	0	3	3	6	0	1	0	0	2	0	0
Overall Study Lack of antiviral response	0	0	12	18	18	18	21	0	0	0	1	0
Overall Study Other reason not defined above	0	0	0	0	0	0	0	1	0	0	0	0

Baseline Characteristics

Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection

Baseline characteristics by cohort

Measure	Part 1: 400mg DBV and 120mg FDV - 4w n=15 Participants Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)	Part 1: 600mg DBV and 120mg FDV - 4w n=17 Participants Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)	Part 2: 600mg DBV and 120mg FDV - 16w n=81 Participants Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV TID and 120mg FDV - 28w n=80 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV - 40w n=77 Participants Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w n=78 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w n=46 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 3: 600mg DBV and 120mg FDV - 16w n=32 Participants Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 3: 800mg DBV and 120mg FDV - 24w n=26 Participants Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 3: 600mg DBV and 120mg FDV - 24w n=25 Participants Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 4: 600 mg DBV and 120mg FDV - 16w n=1 Participants Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.	Part 4: 600 mg DBV and 120mg FDV - 24w n=2 Participants Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.	Total n=480 Participants Total of all reporting groups
Age, Continuous	50.8 Years STANDARD_DEVIATION 10.0 • n=5 Participants	50.8 Years STANDARD_DEVIATION 11.5 • n=7 Participants	48.6 Years STANDARD_DEVIATION 11.3 • n=5 Participants	47.3 Years STANDARD_DEVIATION 11.2 • n=4 Participants	48.9 Years STANDARD_DEVIATION 10.7 • n=21 Participants	47.9 Years STANDARD_DEVIATION 11.1 • n=8 Participants	45.3 Years STANDARD_DEVIATION 13.0 • n=8 Participants	48.9 Years STANDARD_DEVIATION 11.8 • n=24 Participants	47.2 Years STANDARD_DEVIATION 13.4 • n=42 Participants	46.5 Years STANDARD_DEVIATION 12.5 • n=42 Participants	59.0 Years STANDARD_DEVIATION NA • n=42 Participants	52.5 Years STANDARD_DEVIATION 4.9 • n=42 Participants	48.1 Years STANDARD_DEVIATION 11.4 • n=36 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	36 Participants n=5 Participants	39 Participants n=4 Participants	41 Participants n=21 Participants	37 Participants n=8 Participants	22 Participants n=8 Participants	20 Participants n=24 Participants	11 Participants n=42 Participants	11 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	234 Participants n=36 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	45 Participants n=5 Participants	41 Participants n=4 Participants	36 Participants n=21 Participants	41 Participants n=8 Participants	24 Participants n=8 Participants	12 Participants n=24 Participants	15 Participants n=42 Participants	14 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	246 Participants n=36 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: FAS which included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) <25IU/mL at Week 4 of treatment

Outcome measures

Measure	Part 1: 400mg DBV and 120mg FDV - 4w n=15 Participants Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)	Part 1: 600mg DBV and 120mg FDV - 4w n=17 Participants Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)	Part 2: 600mg DBV and 120mg FDV - 40w Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 1: Rapid Virological Response (RVR)	73.3 Percentage of participants Interval 47.6 to 89.0	100.0 Percentage of participants Interval 84.7 to 100.0	—	—	—	—	—

PRIMARY outcome

Timeframe: From drug administration until 12 weeks after end of treatment, up to 52 weeks

Population: FAS

Part 2: Sustained virological response (SVR), defined as HCV RNA <25 IU/mL and undetectable at 12 weeks after end of treatment

Outcome measures

Measure	Part 1: 400mg DBV and 120mg FDV - 4w n=81 Participants Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)	Part 1: 600mg DBV and 120mg FDV - 4w n=80 Participants Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)	Part 2: 600mg DBV and 120mg FDV - 40w n=77 Participants Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w n=78 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w n=46 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: Sustained Virological Response (SVR)	59.3 Percentage of participants	58.8 Percentage of participants	51.9 Percentage of participants	69.2 Percentage of participants	39.1 Percentage of participants	—	—

PRIMARY outcome

Timeframe: From drug administration until 12 weeks after end of treatment, up to 36 weeks

Population: FAS

Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA <25IU/mL and undetectable at 12 weeks after end of treatment

Outcome measures

Measure	Part 1: 400mg DBV and 120mg FDV - 4w n=32 Participants Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)	Part 1: 600mg DBV and 120mg FDV - 4w n=26 Participants Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)	Part 2: 600mg DBV and 120mg FDV - 40w n=25 Participants Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w n=1 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w n=2 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 3 and 4: Sustained Virological Response (SVR)	65.6 Percentage of participants Interval 46.8 to 81.4	19.2 Percentage of participants Interval 6.6 to 39.4	12.0 Percentage of participants Interval 2.5 to 31.2	NA Percentage of participants The study was stopped before data were collected from the participants in Part 4	NA Percentage of participants The study was stopped before data were collected from the participants in Part 4	—	—

SECONDARY outcome

Timeframe: From drug administration until end of drug administration, up to 4 weeks

Population: FAS

Part 1: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.

Outcome measures

Measure	Part 1: 400mg DBV and 120mg FDV - 4w n=15 Participants Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)	Part 1: 600mg DBV and 120mg FDV - 4w n=17 Participants Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)	Part 2: 600mg DBV and 120mg FDV - 40w Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 1: Time to Virological Response <= 2 weeks	6.7 Percentage of participants	11.8 Percentage of participants	—	—	—	—	—
Part 1: Time to Virological Response <= 4 weeks	20.0 Percentage of participants	47.1 Percentage of participants	—	—	—	—	—
Part 1: Time to Virological Response <= 8 weeks	53.3 Percentage of participants	41.2 Percentage of participants	—	—	—	—	—
Part 1: Time to Virological Response <= 12 weeks	0.0 Percentage of participants	0.0 Percentage of participants	—	—	—	—	—
Part 1: Time to Virological Response <= 16 weeks	6.7 Percentage of participants	0.0 Percentage of participants	—	—	—	—	—
Part 1: Time to Virological Response <= 28 weeks	0.0 Percentage of participants	0.0 Percentage of participants	—	—	—	—	—
Part 1: Time to Virological Response <= 32 weeks	6.7 Percentage of participants	0.0 Percentage of participants	—	—	—	—	—
Part 1: Time to Virological Response <= 40 weeks	0.0 Percentage of participants	0.0 Percentage of participants	—	—	—	—	—
Part 1: Time to Virological Response > 40 weeks	0.0 Percentage of participants	0.0 Percentage of participants	—	—	—	—	—
Part 1: Time to Virological Response Never	6.7 Percentage of participants	0.0 Percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: From drug administration until end of drug administration, up to 40 weeks

Population: FAS

Part 2: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.

Outcome measures

Measure	Part 1: 400mg DBV and 120mg FDV - 4w n=81 Participants Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)	Part 1: 600mg DBV and 120mg FDV - 4w n=80 Participants Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)	Part 2: 600mg DBV and 120mg FDV - 40w n=77 Participants Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w n=78 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w n=46 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: Time to Virological Response Day 0 (N=81, 80, 77, 78, 46)	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	—	—
Part 2: Time to Virological Response Day 8(N=75, 72, 72, 75, 44)	3.8 Percentage of participants	7.7 Percentage of participants	1.4 Percentage of participants	2.6 Percentage of participants	2.2 Percentage of participants	—	—
Part 2: Time to Virological Response Day 15 (N=62, 61, 63, 60, 33)	19.4 Percentage of participants	20.7 Percentage of participants	9.9 Percentage of participants	22.1 Percentage of participants	19.3 Percentage of participants	—	—
Part 2: Time to Virological Response Day 29 (N=29, 32, 27, 32, 21)	61.5 Percentage of participants	55.5 Percentage of participants	59.4 Percentage of participants	57.7 Percentage of participants	48.6 Percentage of participants	—	—
Part 2: Time to Virological Response Day 43 (N=16, 12, 13, 18, 12)	78.8 Percentage of participants	83.3 Percentage of participants	80.5 Percentage of participants	76.2 Percentage of participants	70.7 Percentage of participants	—	—
Part 2: Time to Virological Response Day 57 (N=9, 8, 9, 11, 9)	88.1 Percentage of participants	88.9 Percentage of participants	85.1 Percentage of participants	85.5 Percentage of participants	78.0 Percentage of participants	—	—
Part 2: Time to Virological Response Day 85 (N=9, 7, 8, 11, 9)	88.1 Percentage of participants	90.3 Percentage of participants	86.8 Percentage of participants	85.5 Percentage of participants	78.0 Percentage of participants	—	—
Part 2: Time to Virological Response Day 113 (N=9, 7, 8, 11, 8)	88.1 Percentage of participants	90.3 Percentage of participants	86.8 Percentage of participants	85.5 Percentage of participants	80.4 Percentage of participants	—	—
Part 2: Time to Virological Response Day 141 (N=9, 7, 8, 11, 8)	88.1 Percentage of participants	90.3 Percentage of participants	86.8 Percentage of participants	85.5 Percentage of participants	80.4 Percentage of participants	—	—
Part 2: Time to Virological Response Day 169 (N=9, 7, 8, 11, 8)	88.1 Percentage of participants	90.3 Percentage of participants	86.8 Percentage of participants	85.5 Percentage of participants	80.4 Percentage of participants	—	—
Part 2: Time to Virological Response Day 197 (N=9, 7, 8, 11, 8)	88.1 Percentage of participants	90.3 Percentage of participants	86.8 Percentage of participants	85.5 Percentage of participants	80.4 Percentage of participants	—	—

SECONDARY outcome

Timeframe: 4 weeks

Population: FAS

Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4

Outcome measures

Measure	Part 1: 400mg DBV and 120mg FDV - 4w n=15 Participants Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)	Part 1: 600mg DBV and 120mg FDV - 4w n=17 Participants Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)	Part 2: 600mg DBV and 120mg FDV - 40w n=81 Participants Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w n=80 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w n=77 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w n=78 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w n=46 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4	20.0 Percentage of participants	70.6 Percentage of participants	65.4 Percentage of participants	60.0 Percentage of participants	63.6 Percentage of participants	56.4 Percentage of participants	50.0 Percentage of participants

SECONDARY outcome

Timeframe: 4 weeks and 24 weeks after the end of treatment, up to 64 weeks

Population: FAS

Part 2: Sustained virological response at 4 and 24 weeks after end of treatment

Outcome measures

Measure	Part 1: 400mg DBV and 120mg FDV - 4w n=81 Participants Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)	Part 1: 600mg DBV and 120mg FDV - 4w n=80 Participants Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)	Part 2: 600mg DBV and 120mg FDV - 40w n=77 Participants Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w n=78 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w n=46 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment SVR4	60.5 Percentage of participants	62.5 Percentage of participants	54.5 Percentage of participants	69.2 Percentage of participants	43.5 Percentage of participants	—	—
Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment SVR24	58.0 Percentage of participants	58.8 Percentage of participants	49.4 Percentage of participants	69.2 Percentage of participants	39.1 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 4 and 12

Population: FAS

Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level <25 IU/mL at week 4 and 12 of treatment

Outcome measures

Measure	Part 1: 400mg DBV and 120mg FDV - 4w n=32 Participants Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)	Part 1: 600mg DBV and 120mg FDV - 4w n=26 Participants Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)	Part 2: 600mg DBV and 120mg FDV - 40w n=25 Participants Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w n=1 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w n=2 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment	75.0 Percentage of participants	26.9 Percentage of participants	32.0 Percentage of participants	NA Percentage of participants The study was stopped before data were collected from the participants in Part 4	NA Percentage of participants The study was stopped before data were collected from the participants in Part 4	—	—

SECONDARY outcome

Timeframe: up to 28 weeks

Population: FAS

Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment

Outcome measures

Measure	Part 1: 400mg DBV and 120mg FDV - 4w n=32 Participants Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)	Part 1: 600mg DBV and 120mg FDV - 4w n=26 Participants Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)	Part 2: 600mg DBV and 120mg FDV - 40w n=25 Participants Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w n=1 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w n=2 Participants Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment	75.0 Percentage of participants Interval 56.6 to 88.5	19.2 Percentage of participants Interval 6.6 to 39.4	12.0 Percentage of participants Interval 2.5 to 31.2	NA Percentage of participants The study was stopped before data were collected from the participants in Part 4	NA Percentage of participants The study was stopped before data were collected from the participants in Part 4	—	—

Adverse Events

Part 1: 400mg DBV and 120mg FDV - 4w

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: 600mg DBV and 120mg FDV - 4w

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: 600mg DBV and 120mg FDV - 16w

Serious events: 3 serious events

Other events: 76 other events

Deaths: 0 deaths

Part 2: 600mg DBV TID and 120mg FDV - 28w

Serious events: 8 serious events

Other events: 71 other events

Deaths: 0 deaths

Part 2: 600mg DBV and 120mg FDV - 40w

Serious events: 6 serious events

Other events: 74 other events

Deaths: 0 deaths

Part 2: 600mg DBV BID and 120mg FDV - 28w

Serious events: 8 serious events

Other events: 73 other events

Deaths: 0 deaths

Part 2: 600mg DBV and 120mg FDV, no RBV - 28w

Serious events: 3 serious events

Other events: 43 other events

Deaths: 0 deaths

Part 3: 600mg DBV and 120mg FDV - 16w

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Part 3: 800mg DBV and 120mg FDV - 24w

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

Part 3: 600mg DBV and 120mg FDV - 24w

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Part 4: 600 mg DBV and 120mg FDV - 16w

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 4: 600 mg DBV and 120mg FDV - 24w

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1: 400mg DBV and 120mg FDV - 4w n=15 participants at risk Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)	Part 1: 600mg DBV and 120mg FDV - 4w n=17 participants at risk Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)	Part 2: 600mg DBV and 120mg FDV - 16w n=81 participants at risk Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV TID and 120mg FDV - 28w n=80 participants at risk Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV - 40w n=77 participants at risk Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w n=78 participants at risk Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w n=46 participants at risk Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 3: 600mg DBV and 120mg FDV - 16w n=32 participants at risk Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 3: 800mg DBV and 120mg FDV - 24w n=26 participants at risk Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 3: 600mg DBV and 120mg FDV - 24w n=25 participants at risk Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 4: 600 mg DBV and 120mg FDV - 16w n=1 participants at risk Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.	Part 4: 600 mg DBV and 120mg FDV - 24w n=2 participants at risk Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
Hepatobiliary disorders Cholecystitis	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Nervous system disorders Convulsion	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Cardiac disorders Coronary artery disease	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Cardiac disorders Coronary artery stenosis	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Metabolism and nutrition disorders Dehydration	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.1% 1/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Abdominal pain	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Injury, poisoning and procedural complications Accident at work	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Cardiac disorders Acute myocardial infarction	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Blood and lymphatic system disorders Anaemia	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Cardiac disorders Angina unstable	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
General disorders Asthenia	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Investigations Blood potassium decreased	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Nervous system disorders Brain injury	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Cardiac disorders Bundle branch block left	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Cardiac disorders Cardiac arrest	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Cardiac disorders Cardiopulmonary failure	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Infections and infestations Cellulitis pharyngeal	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Psychiatric disorders Depression	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Diarrhoea	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.2% 1/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Investigations Electrocardiogram QT prolonged	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Erythema nodosum	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Gastritis	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.1% 1/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Infections and infestations Gastroenteritis	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.2% 1/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Haemorrhoids	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Infections and infestations Herpes zoster	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Cardiac disorders Myocardial infarction	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Nausea	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Renal and urinary disorders Prerenal failure	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.1% 1/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Psychiatric disorders Psychotic disorder	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Purpura	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.2% 1/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Injury, poisoning and procedural complications Radius fracture	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Rash	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Renal and urinary disorders Renal failure acute	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Eye disorders Retinal tear	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Nervous system disorders Syncope	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Toxic skin eruption	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.2% 1/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Cardiac disorders Ventricular fibrillation	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Vomiting	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days

Other adverse events

Measure	Part 1: 400mg DBV and 120mg FDV - 4w n=15 participants at risk Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)	Part 1: 600mg DBV and 120mg FDV - 4w n=17 participants at risk Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)	Part 2: 600mg DBV and 120mg FDV - 16w n=81 participants at risk Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV TID and 120mg FDV - 28w n=80 participants at risk Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV - 40w n=77 participants at risk Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV BID and 120mg FDV - 28w n=78 participants at risk Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 2: 600mg DBV and 120mg FDV, no RBV - 28w n=46 participants at risk Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 3: 600mg DBV and 120mg FDV - 16w n=32 participants at risk Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 3: 800mg DBV and 120mg FDV - 24w n=26 participants at risk Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 3: 600mg DBV and 120mg FDV - 24w n=25 participants at risk Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.	Part 4: 600 mg DBV and 120mg FDV - 16w n=1 participants at risk Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.	Part 4: 600 mg DBV and 120mg FDV - 24w n=2 participants at risk Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
Gastrointestinal disorders Constipation	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.9% 4/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.8% 6/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 3/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.2% 1/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	12.5% 4/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	15.4% 4/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.6% 7/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.0% 4/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	13.0% 10/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	11.5% 9/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.3% 2/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 2/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 2/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.0% 2/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Abdominal discomfort	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 6/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	12.5% 4/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 2/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.0% 2/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Abdominal distension	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.9% 4/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 3/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	9.1% 7/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.1% 4/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.5% 3/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.1% 1/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Abdominal pain	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.6% 7/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.8% 7/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.8% 6/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	15.4% 12/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	17.4% 8/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	11.5% 3/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	12.0% 3/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Abdominal pain upper	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.4% 6/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	18.8% 15/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	15.6% 12/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.6% 2/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.3% 2/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	9.4% 3/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	19.2% 5/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.0% 2/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	50.0% 1/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.8% 7/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.6% 2/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	9.0% 7/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.7% 4/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.1% 1/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 2/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Blood and lymphatic system disorders Anaemia	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	11.2% 9/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	13.0% 10/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	9.0% 7/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	25.0% 8/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	11.5% 3/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.0% 2/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	100.0% 1/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Psychiatric disorders Anxiety	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.7% 3/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.0% 4/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	9.1% 7/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.1% 4/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 2/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 2/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	50.0% 1/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.9% 4/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 5/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.2% 4/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.1% 4/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.5% 3/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
General disorders Asthenia	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	29.6% 24/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	35.0% 28/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	32.5% 25/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	26.9% 21/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	15.2% 7/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	21.9% 7/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	15.4% 4/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.7% 3/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 3/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 6/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.1% 1/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
General disorders Chest pain	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 2/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	50.0% 1/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
General disorders Chills	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 5/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.5% 2/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.9% 3/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.6% 2/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.3% 2/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.1% 1/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Metabolism and nutrition disorders Decreased appetite	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.9% 4/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	18.8% 15/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	13.0% 10/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	10.3% 8/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	9.4% 3/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Psychiatric disorders Depressed mood	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.5% 2/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.5% 5/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.6% 2/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Psychiatric disorders Depression	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	12.5% 10/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.5% 5/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.4% 5/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.2% 1/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 2/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.0% 2/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	50.0% 1/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.0% 2/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Diarrhoea	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	42.0% 34/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	41.2% 33/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	46.8% 36/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	37.2% 29/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	26.1% 12/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	21.9% 7/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	34.6% 9/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	36.0% 9/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Nervous system disorders Disturbance in attention	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.7% 3/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.0% 4/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.2% 4/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 3/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.5% 3/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.1% 1/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Nervous system disorders Dizziness	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.9% 4/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 3/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.5% 5/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 3/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.2% 1/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	15.6% 5/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	12.0% 3/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	50.0% 1/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Eye disorders Dry eye	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.9% 3/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 2/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Dry mouth	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.2% 4/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	14.8% 12/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	15.0% 12/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	14.3% 11/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	23.1% 18/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	15.2% 7/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	9.4% 3/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 2/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.0% 2/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Nervous system disorders Dysgeusia	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.7% 3/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.0% 4/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.5% 5/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.6% 2/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.3% 2/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 2/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Dyspepsia	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.4% 6/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 5/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	10.4% 8/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	17.9% 14/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.7% 4/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	18.8% 6/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	15.4% 4/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.5% 2/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	10.0% 8/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	13.0% 10/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.1% 4/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	50.0% 1/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Eczema	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.5% 2/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 3/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.6% 2/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.1% 4/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.5% 3/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.2% 4/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Erythema	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.6% 2/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.1% 1/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	12.0% 3/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
General disorders Fatigue	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	22.2% 18/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	17.5% 14/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	28.6% 22/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	26.9% 21/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	15.2% 7/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	28.1% 9/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	34.6% 9/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	40.0% 10/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	100.0% 1/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Flatulence	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.7% 3/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 5/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.2% 4/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.1% 4/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.3% 2/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 2/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.0% 4/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.6% 2/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.6% 2/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.1% 1/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 2/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.0% 2/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	50.0% 1/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Nervous system disorders Headache	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	13.6% 11/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	10.0% 8/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	19.5% 15/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	14.1% 11/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	15.2% 7/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	12.5% 4/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	11.5% 3/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.0% 2/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	100.0% 2/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.5% 2/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.9% 3/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	9.4% 3/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	50.0% 1/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Nervous system disorders Hypoaesthesia	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.6% 2/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	12.0% 3/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.2% 1/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.1% 1/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.0% 2/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
General disorders Influenza like illness	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.5% 2/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.5% 6/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.5% 5/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.4% 5/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.3% 2/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Psychiatric disorders Insomnia	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	13.6% 11/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	10.0% 8/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	15.6% 12/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	9.0% 7/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.3% 2/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	12.5% 4/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	11.5% 3/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	20.0% 5/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
General disorders Irritability	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	9.9% 8/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.5% 6/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.2% 4/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.6% 2/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.2% 1/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.0% 2/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Hepatobiliary disorders Jaundice	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	30.9% 25/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	27.5% 22/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	19.5% 15/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	20.5% 16/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.3% 2/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	18.8% 6/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	19.2% 5/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	16.0% 4/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Nervous system disorders Lethargy	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.6% 2/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.2% 1/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 2/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Lip dry	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.5% 2/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.7% 4/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.9% 4/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.8% 6/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 3/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.2% 1/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.1% 1/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 2/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.0% 4/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.2% 4/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 3/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.2% 1/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 2/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Infections and infestations Nasopharyngitis	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.9% 4/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	10.0% 8/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	9.1% 7/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 6/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	13.0% 6/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 2/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Nausea	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	50.6% 41/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	53.8% 43/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	53.2% 41/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	50.0% 39/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	56.5% 26/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	56.2% 18/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	61.5% 16/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	72.0% 18/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	100.0% 1/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	50.0% 1/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Eye disorders Ocular icterus	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.5% 2/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.9% 3/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.4% 5/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 2/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 2/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
General disorders Oedema peripheral	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.5% 2/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 2/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.5% 2/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.6% 2/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 3/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.2% 1/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.1% 1/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 2/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.0% 2/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	50.0% 1/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Papule	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 2/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Nervous system disorders Paraesthesia	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	12.3% 10/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	11.2% 9/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.8% 6/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.1% 4/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	10.9% 5/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	11.5% 3/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.0% 2/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	24.7% 20/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	28.7% 23/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	29.9% 23/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	24.4% 19/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	23.9% 11/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	12.5% 4/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	11.5% 3/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	32.0% 8/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	50.0% 1/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	19.8% 16/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	30.0% 24/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	40.3% 31/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	29.5% 23/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	30.4% 14/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	21.9% 7/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	23.1% 6/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	28.0% 7/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	100.0% 2/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
General disorders Pyrexia	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.0% 4/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.2% 4/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.1% 4/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.2% 1/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.1% 1/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 2/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Rash	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	25.9% 21/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	13.8% 11/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	36.4% 28/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	19.2% 15/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	28.3% 13/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	34.6% 9/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	40.0% 10/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	100.0% 2/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Skin and subcutaneous tissue disorders Rash papulosquamous	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 2/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Psychiatric disorders Sleep disorder	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.7% 3/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.0% 4/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	9.1% 7/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.1% 4/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.3% 2/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.8% 1/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Nervous system disorders Somnolence	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.5% 2/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.1% 1/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	15.4% 4/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Injury, poisoning and procedural complications Sunburn	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.4% 6/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	5.0% 4/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	11.7% 9/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 6/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	17.4% 8/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	3.1% 1/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 2/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	16.0% 4/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Nervous system disorders Syncope	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.5% 2/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.5% 5/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 6/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Ear and labyrinth disorders Tinnitus	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 2/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Nervous system disorders Tremor	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.3% 1/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.2% 1/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 2/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Infections and infestations Urinary tract infection	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	1.2% 1/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.5% 2/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.6% 2/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	2.2% 1/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	6.2% 2/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	4.0% 1/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Gastrointestinal disorders Vomiting	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	29.6% 24/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	36.2% 29/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	29.9% 23/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	25.6% 20/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	28.3% 13/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	34.4% 11/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	23.1% 6/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	20.0% 5/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Investigations Weight decreased	0.00% 0/15 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/17 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	9.9% 8/81 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.5% 6/80 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	14.3% 11/77 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	10.3% 8/78 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.7% 4/46 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/32 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	7.7% 2/26 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	8.0% 2/25 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/1 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days	0.00% 0/2 • From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER