Trial Outcomes & Findings for Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2) (NCT NCT00774397)

Last Updated: 2015-11-16

Results Overview

An achieved virological response is defined as the plasma Hepatitis C Virus RiboNucleic Acid (HCV RNA) level below the lower limit of detection (BLD). This data was only collected for patients, who stopped trial participation at Week 24 and did not continue with PegIFN/RBV until Week 48. The lower limit of quantification (BLQ) of this assay was 25 IU/mL and the lower limit of detection (BLD) was 10 IU/mL at the time of the protocol finalisation. During the course of the trial, the manufacturer defined BLD as '\< 25 IU/mL, not detectable' and BLQ as '\< 25 IU/mL, detectable'.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

719 participants

Primary outcome timeframe

Week 28

Results posted on

2015-11-16

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo-TN Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV (Pegylated interferon α-2a (Pegasys®)/ Ribavirin (Copegus®)): PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Overall Study STARTED	71	69	143	146	143	76	71
Overall Study COMPLETED	57	56	113	129	97	54	41
Overall Study NOT COMPLETED	14	13	30	17	46	22	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo-TN Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV (Pegylated interferon α-2a (Pegasys®)/ Ribavirin (Copegus®)): PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Overall Study Adverse Event	1	3	16	8	8	3	16
Overall Study Lack of Efficacy	11	4	5	3	27	15	9
Overall Study Protocol Violation	0	1	3	1	2	1	0
Overall Study Lost to Follow-up	0	1	1	1	0	1	0
Overall Study Refused to continue trial medication	1	3	2	2	6	2	3
Overall Study Not treated	0	0	0	0	1	0	1
Overall Study Other than those stated above	1	1	3	2	2	0	1

Baseline Characteristics

Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=143 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=146 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	Total n=717 Participants Total of all reporting groups
Age, Continuous	45.6 years STANDARD_DEVIATION 10.86 • n=5 Participants	46.3 years STANDARD_DEVIATION 10.92 • n=7 Participants	44.7 years STANDARD_DEVIATION 10.18 • n=5 Participants	46.3 years STANDARD_DEVIATION 10.48 • n=4 Participants	48.7 years STANDARD_DEVIATION 9.58 • n=21 Participants	49.6 years STANDARD_DEVIATION 8.42 • n=8 Participants	50.1 years STANDARD_DEVIATION 8.34 • n=8 Participants	47.14 years STANDARD_DEVIATION 9.91 • n=24 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	29 Participants n=7 Participants	69 Participants n=5 Participants	67 Participants n=4 Participants	41 Participants n=21 Participants	26 Participants n=8 Participants	29 Participants n=8 Participants	291 Participants n=24 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	40 Participants n=7 Participants	74 Participants n=5 Participants	79 Participants n=4 Participants	101 Participants n=21 Participants	50 Participants n=8 Participants	41 Participants n=8 Participants	426 Participants n=24 Participants

PRIMARY outcome

Timeframe: Week 28

Population: Per protocol set (PPS): PPS was subset of full analysis set,consisted of all patients without important protocol deviations . FAS was composed of all randomised patients who took at least 1 dose of study medication. For this outcome, only patients who were not on PegIFN/RBV treatment 4 weeks after stop of BI 201335 or Placebo were investigated.

Outcome measures

Outcome measures
Measure	Placebo-TN n=13 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=14 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=77 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=72 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=88 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=30 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=27 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo	0.0 percentage of patients	14.3 percentage of patients	59.7 percentage of patients	75.0 percentage of patients	20.5 percentage of patients	3.3 percentage of patients	0.0 percentage of patients

PRIMARY outcome

Timeframe: Day 155 after the end of all treatment

Population: Per protocol set

Virological (VL) response was defined as the plasma HCV RNA level below the lower limit of detection. The first VL measurement that occurred in the time window ≥ Day 155 (from End Of Treatment on) was selected for the determination of SVR24. Therefore, patients with virological load BLD 24 weeks after completion of therapy, who had a rebound after this time point (outside the defined time window of 155 days after end of all treatments) were identified as SVR24 achieved.

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=141 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Sustained Virological Response 24 Weeks (SVR24) After Completion of All Therapy	56.3 percentage of patients Interval 44.7 to 67.3	72.5 percentage of patients Interval 60.9 to 81.6	72.3 percentage of patients Interval 64.4 to 79.1	83.8 percentage of patients Interval 76.9 to 88.9	28.2 percentage of patients Interval 21.4 to 36.1	40.8 percentage of patients Interval 30.4 to 52.1	31.4 percentage of patients Interval 21.8 to 43.1

SECONDARY outcome

Timeframe: Week 2

Population: Per protocol set

Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 2 (\< 25 IU/ml, detectable or undetectable)

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=141 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Virological Response at Week 2	1.4 percentage of patients	69.6 percentage of patients	66.7 percentage of patients	82.4 percentage of patients	27.5 percentage of patients	34.2 percentage of patients	47.1 percentage of patients

SECONDARY outcome

Timeframe: Week 4

Population: Per protocol set

Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 4 (\< 25 IU/ml, detectable or undetectable)

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=141 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Virological Response at Week 4	16.9 percentage of patients	89.9 percentage of patients	86.5 percentage of patients	93.7 percentage of patients	63.4 percentage of patients	60.5 percentage of patients	68.6 percentage of patients

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Per protocol set

Early Virological Response (EVR) is defined as ≥ 2 log 10 reduction in plasma HCV RNA level from baseline at Week 12

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=141 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Early Virological Response (EVR)	84.5 percentage of patients	89.9 percentage of patients	88.7 percentage of patients	93.0 percentage of patients	72.5 percentage of patients	76.3 percentage of patients	62.9 percentage of patients

SECONDARY outcome

Timeframe: Week 4 and Week 12

Population: Per protocol set

Extended Rapid Virological Response (eRVR) is defined as plasma HCV RNA levels below the lower limit of quantification at Week 4 and below the lower limit of detection at Week 12

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=141 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Extended Rapid Virological Response (eRVR)	15.5 percentage of patients	85.5 percentage of patients	80.9 percentage of patients	90.8 percentage of patients	52.1 percentage of patients	52.6 percentage of patients	51.4 percentage of patients

SECONDARY outcome

Timeframe: Week 12

Population: Per protocol set

Complete Early Virological Response (cEVR) is defined as plasma HCV RNA level below the lower limit of detection at Week 12

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=141 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Complete Early Virological Response (cEVR)	42.3 percentage of patients	87.0 percentage of patients	84.4 percentage of patients	93.0 percentage of patients	58.5 percentage of patients	59.2 percentage of patients	52.9 percentage of patients

SECONDARY outcome

Timeframe: Week 24

Population: Per protocol set

End of Treatment Response of BI 201335 or placebo (ETR BI 201335/placebo ) is defined as plasma HCV RNA level below the lower limit of detection at Week 24.

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=141 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
End of Treatment Response at Week 24	73.2 percentage of patients	82.6 percentage of patients	77.3 percentage of patients	88.0 percentage of patients	58.5 percentage of patients	52.6 percentage of patients	52.9 percentage of patients

SECONDARY outcome

Timeframe: Week 24 or Week 48

Population: Per protocol set

End of Treatment Response (ETR) is defined as plasma HCV RNA level below the lower limit of detection at end of all therapy, i.e. at Week 24 or Week 48

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=141 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
End of Treatment Response at End of All Therapy	69.0 percentage of patients	72.5 percentage of patients	78.0 percentage of patients	81.7 percentage of patients	48.6 percentage of patients	46.1 percentage of patients	45.7 percentage of patients

SECONDARY outcome

Timeframe: Week 36 or Week 60

Population: Per protocol set

Sustained Virological Response 12 Weeks (SVR12) after completion of all therapy is defined as plasma HCV RNA level below the lower limit of detection at 12 weeks after completion of all therapy, i.e. at Week 36 or 60

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=141 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Sustained Virological Response 12 Weeks (SVR12) After Completion of All Therapy	50.7 percentage of patients	68.1 percentage of patients	65.2 percentage of patients	74.6 percentage of patients	26.1 percentage of patients	35.5 percentage of patients	27.1 percentage of patients

SECONDARY outcome

Timeframe: On or after day 155 post end of all treatment

Population: Per protocol set

Summary of time (i.e Median number of days) to reach a plasma HCV RNA level below limit of detection (BLD)

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=141 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Time to Reach a Plasma HCV RNA Level Below the Lower Limit of Detection	113 Days Interval 29.0 to 197.0	29 Days Interval 8.0 to 113.0	29 Days Interval 4.0 to 113.0	29 Days Interval 4.0 to 113.0	56 Days Interval 8.0 to 143.0	56 Days Interval 8.0 to 169.0	29 Days Interval 15.0 to 143.0

SECONDARY outcome

Timeframe: Week 24

Population: Per protocol set

Time to loss of virological response, defined as the last value below the lower limit of detection in a patient who subsequently had 2 consecutive plasma HCV RNA level measurements ≥100 IU/mL. Patients that did not achieve suppression of plasma HCV RNA levels below the lower limit of detection until Week 24 were defined as having a time to failure of zero. Time is expressed in Median number of days.

Outcome measures

Outcome measures
Measure	Placebo-TN n=57 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=64 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=128 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=138 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=100 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=50 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=48 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Time to Loss of Virological Response	NA Number of days More than 50% of all patients of the respective group have no loss of virological response at all, therefore no median can be calculated	NA Number of days More than 50% of all patients of the respective group have no loss of virological response at all, therefore no median can be calculated	NA Number of days More than 50% of all patients of the respective group have no loss of virological response at all, therefore no median can be calculated	NA Number of days More than 50% of all patients of the respective group have no loss of virological response at all, therefore no median can be calculated	230 Number of days Interval 0.0 to NA stands for infinity	370 Number of days Interval 0.0 to NA stands for infinity	370 Number of days Interval 0.0 to NA stands for infinity

SECONDARY outcome

Timeframe: Week 24 or Week 48

Population: Per protocol set

Virological rebound is defined as increase of ≥ 1 log 10 in plasma HCV RNA level from a quantifiable nadir, or to ≥ 250 IU/mL after previous nadir \< 25 IU/mL (detectable), or to ≥ 100 IU/mL after a previous viral load below the lower limit of detection. Note that this is numerical rebound, not requiring confirmation with a re-measurement.

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=141 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Virological Rebound	28.2 percentage of patients	17.4 percentage of patients	19.9 percentage of patients	12.0 percentage of patients	67.6 percentage of patients	53.9 percentage of patients	60.0 percentage of patients

SECONDARY outcome

Timeframe: Up to Week 24

Population: Per protocol set

Number of patients with Unconfirmed rebound ( ≥ 1log10 increase in HCV mRNA) while on BI201335/placebo + 5 days washout.

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=141 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Breakthrough on BI 201335/Placebo (Rebound While All 3 Treatments Were Still Ongoing)	4.2 percentage of patients	5.8 percentage of patients	5.0 percentage of patients	3.5 percentage of patients	25.4 percentage of patients	28.9 percentage of patients	17.1 percentage of patients

SECONDARY outcome

Timeframe: Week 24 through Week 48

Population: Per protocol set

Number of patients with Unconfirmed rebound (≥ 1log10 increase in HCV mRNA) while on PegIFN/RBV treatment + 5 days washout.

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=141 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Breakthrough on PegIFN/RBV (Rebound While Only PegIFN/RBV Treatment Alone Was Still Ongoing)	4.2 percentage of patients	2.9 percentage of patients	0.7 percentage of patients	0.0 percentage of patients	4.9 percentage of patients	6.6 percentage of patients	7.1 percentage of patients

SECONDARY outcome

Timeframe: post-End of treatment (i.e. post 48 weeks)

Population: Per protocol set

Relapse was rebound after the viral load at end of all treatment had been below the lower limit of detection, or, if the value at end of all treatment was missing, after both the last value before End of Treatment (EOT) and the first value after End of Treatment were below the lower limit of detection. Patients could experience relapse at any point post-treatment.

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=141 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Relapse	15.5 percentage of patients	7.2 percentage of patients	10.6 percentage of patients	7.7 percentage of patients	26.8 percentage of patients	11.8 percentage of patients	20.0 percentage of patients

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Treated Set (for patients with change from baseline in Systolic blood pressure and Diastolic blood pressure at Week 24)

Baseline is defined as the last value before the initial drug administration of BI 201335 or placebo.

Outcome measures

Outcome measures
Measure	Placebo-TN n=61 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=60 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=115 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=130 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=102 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=55 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=42 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Change From Baseline to Week 24 in Diastolic Blood Pressure and Systolic Blood Pressure Diastolic Blood Pressure	-0.5 mmHg Standard Deviation 9.11	0.8 mmHg Standard Deviation 12.41	-1.4 mmHg Standard Deviation 10.87	-1.9 mmHg Standard Deviation 10.19	-1.4 mmHg Standard Deviation 9.34	-1.8 mmHg Standard Deviation 10.39	-5.3 mmHg Standard Deviation 10.27
Change From Baseline to Week 24 in Diastolic Blood Pressure and Systolic Blood Pressure Systolic Blood Pressure	-2.6 mmHg Standard Deviation 11.48	-3.8 mmHg Standard Deviation 15.51	-4.6 mmHg Standard Deviation 14.59	-3.2 mmHg Standard Deviation 13.63	-1.8 mmHg Standard Deviation 14.21	-3.4 mmHg Standard Deviation 12.85	-8.0 mmHg Standard Deviation 14.38

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Treated Set (for patients with change from baseline in Pulse rate at Week 24)

Baseline is defined as the last value before the administration of BI 201335 or placebo.

Outcome measures

Outcome measures
Measure	Placebo-TN n=61 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=60 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=115 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=130 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=102 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=55 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=42 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Change From Baseline to Week 24 in Pulse Rate	4.1 bpm Standard Deviation 10.22	3.1 bpm Standard Deviation 11.37	4.1 bpm Standard Deviation 14.53	5.3 bpm Standard Deviation 11.45	5.5 bpm Standard Deviation 11.30	7.6 bpm Standard Deviation 10.77	3.1 bpm Standard Deviation 13.46

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Treated Set (for patients with change from baseline in Weight at Week 24)

Baseline is defined as the last value before the administration of BI 201335 or placebo.

Outcome measures

Outcome measures
Measure	Placebo-TN n=61 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=60 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=115 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=130 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=101 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=55 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=42 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Change From Baseline to Week 24 in Weight of the Patients	-3.3 kg Standard Deviation 3.11	-3.7 kg Standard Deviation 3.14	-4.2 kg Standard Deviation 3.81	-4.8 kg Standard Deviation 5.07	-3.4 kg Standard Deviation 3.36	-4.3 kg Standard Deviation 3.67	-4.8 kg Standard Deviation 4.40

SECONDARY outcome

Timeframe: Week 24

Population: Per protocol set

The investigator was to assess the tolerability of trial medication based on adverse events (AEs) and the laboratory evaluation. Tolerability was assessed by the investigator according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=141 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Global Assessment of Tolerability Good	46.5 percentage of patients	40.6 percentage of patients	41.1 percentage of patients	47.2 percentage of patients	41.5 percentage of patients	31.6 percentage of patients	20.0 percentage of patients
Global Assessment of Tolerability Satisfactory	33.8 percentage of patients	36.2 percentage of patients	36.2 percentage of patients	31.7 percentage of patients	33.1 percentage of patients	40.8 percentage of patients	37.1 percentage of patients
Global Assessment of Tolerability Not satisfactory	8.5 percentage of patients	11.6 percentage of patients	12.1 percentage of patients	12.0 percentage of patients	13.4 percentage of patients	14.5 percentage of patients	22.9 percentage of patients
Global Assessment of Tolerability Bad	5.6 percentage of patients	2.9 percentage of patients	5.0 percentage of patients	6.3 percentage of patients	9.2 percentage of patients	9.2 percentage of patients	20.0 percentage of patients
Global Assessment of Tolerability Not assessable	1.4 percentage of patients	2.9 percentage of patients	4.3 percentage of patients	0.0 percentage of patients	1.4 percentage of patients	0.0 percentage of patients	0.0 percentage of patients
Global Assessment of Tolerability Missing	4.2 percentage of patients	5.8 percentage of patients	1.4 percentage of patients	2.8 percentage of patients	1.4 percentage of patients	3.9 percentage of patients	0.0 percentage of patients

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Treated Set (for patients with change from baseline in Haemoglobin at Week 24)

Baseline is defined as the last value before the administration of BI 201335 or placebo.

Outcome measures

Outcome measures
Measure	Placebo-TN n=60 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=59 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=114 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=129 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=103 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=55 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=40 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Change From Baseline to Week 24 in Haemoglobin of the Patients	-3.51 g/dL Standard Deviation 1.526	-3.41 g/dL Standard Deviation 1.406	-3.41 g/dL Standard Deviation 1.177	-3.43 g/dL Standard Deviation 1.493	-3.19 g/dL Standard Deviation 1.447	-3.41 g/dL Standard Deviation 1.285	-3.82 g/dL Standard Deviation 1.997

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Treated Set (for patients with normal or high baseline Haemoglobin)

Number of patients with normal or high baseline moved to low .

Outcome measures

Outcome measures
Measure	Placebo-TN n=70 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=67 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=137 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=146 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=139 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=67 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Haemoglobin	64.3 percentage of patients	62.7 percentage of patients	51.1 percentage of patients	53.4 percentage of patients	45.3 percentage of patients	63.2 percentage of patients	53.7 percentage of patients

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Treated Set (for patients with change from baseline in Absolute Neutrophils at Week 24)

Baseline is defined as the last value before the administration of BI 201335 or placebo.

Outcome measures

Outcome measures
Measure	Placebo-TN n=58 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=58 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=111 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=129 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=102 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=55 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=39 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Change From Baseline to Week 24 in Absolute Neutrophils of the Patients	-2.57 GI/L Standard Deviation 1.784	-1.84 GI/L Standard Deviation 1.497	-1.83 GI/L Standard Deviation 2.788	-2.10 GI/L Standard Deviation 1.551	-1.87 GI/L Standard Deviation 1.567	-1.47 GI/L Standard Deviation 1.680	-1.84 GI/L Standard Deviation 1.885

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Treated Set (for patients with normal or high baseline Absolute Neutrophils)

Number of patients with normal or high baseline moved to low .

Outcome measures

Outcome measures
Measure	Placebo-TN n=68 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=65 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=134 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=139 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=126 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=66 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=57 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Absolute Neutrophils	70.6 percentage of patients	66.2 percentage of patients	47.8 percentage of patients	45.3 percentage of patients	50.0 percentage of patients	54.5 percentage of patients	47.4 percentage of patients

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Treated Set (for patients with change from baseline in ALT/GPT,SGPT at Week 24)

Baseline is defined as the last value before the drug administration of BI 201335 or placebo.

Outcome measures

Outcome measures
Measure	Placebo-TN n=60 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=60 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=116 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=130 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=102 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=55 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=42 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Change From Baseline to Week 24 in ALT/GPT,SGPT of the Patients	-92.0 U/L Standard Deviation 86.98	-67.7 U/L Standard Deviation 65.95	-64.2 U/L Standard Deviation 80.46	-70.2 U/L Standard Deviation 92.76	-50.8 U/L Standard Deviation 77.43	-62.0 U/L Standard Deviation 68.60	-61.0 U/L Standard Deviation 80.46

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Treated Set (for patients with normal or low baseline ALT/GPT,SGPT)

Number of patients with normal or low baseline moved to high .

Outcome measures

Outcome measures
Measure	Placebo-TN n=11 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=10 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=32 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=26 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=24 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=6 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=10 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter ALT/GPT,SGPT	0.0 percentage of patients	10.0 percentage of patients	3.1 percentage of patients	0.0 percentage of patients	8.3 percentage of patients	16.7 percentage of patients	20.0 percentage of patients

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Treated Set (for patients with change from baseline in Total Bilirubin at Week 24)

Baseline is defined as the last value before the administration of BI 201335 or placebo.

Outcome measures

Outcome measures
Measure	Placebo-TN n=61 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=60 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=116 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=130 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=103 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=55 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=42 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Change From Baseline to Week 24 in Total Bilirubin of the Patients	0.03 mg/dL Standard Deviation 0.181	0.70 mg/dL Standard Deviation 0.625	1.65 mg/dL Standard Deviation 1.279	1.51 mg/dL Standard Deviation 0.983	1.37 mg/dL Standard Deviation 0.959	1.09 mg/dL Standard Deviation 0.996	3.04 mg/dL Standard Deviation 2.203

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Treated Set (for patients with normal or low baseline Total Bilirubin)

Number of patients with normal or low baseline moved to high .

Outcome measures

Outcome measures
Measure	Placebo-TN n=69 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=66 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=132 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=146 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=136 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=74 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=68 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Total Bilirubin	0.0 percentage of patients	9.1 percentage of patients	15.9 percentage of patients	8.9 percentage of patients	29.4 percentage of patients	17.6 percentage of patients	33.8 percentage of patients

SECONDARY outcome

Timeframe: Week 8, week 10, week 12, week 24

Population: All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.

C(pre,ss) is defined as pre-dose (trough) concentration of Faldaprevir in plasma at steady state immediately before administration of the next dose.

Outcome measures

Outcome measures
Measure	Placebo-TN n=69 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=143 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=146 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=70 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Trough Concentration (Cpre,ss) of Faldaprevir at Steady State week 8(N=52,108,116,107,47,32)	1310 ng/mL Geometric Coefficient of Variation 81.7	6550 ng/mL Geometric Coefficient of Variation 106	6190 ng/mL Geometric Coefficient of Variation 169	7230 ng/mL Geometric Coefficient of Variation 94.3	6410 ng/mL Geometric Coefficient of Variation 95.4	51100 ng/mL Geometric Coefficient of Variation 55.1	—
Trough Concentration (Cpre,ss) of Faldaprevir at Steady State week 10(N=54,98,101,94,54,29)	1220 ng/mL Geometric Coefficient of Variation 91.3	6530 ng/mL Geometric Coefficient of Variation 118	6340 ng/mL Geometric Coefficient of Variation 99.7	6370 ng/mL Geometric Coefficient of Variation 137	7020 ng/mL Geometric Coefficient of Variation 108	43500 ng/mL Geometric Coefficient of Variation 72.2	—
Trough Concentration (Cpre,ss) of Faldaprevir at Steady State week 12(N=53,113,119,105,56,30)	1240 ng/mL Geometric Coefficient of Variation 91.1	6380 ng/mL Geometric Coefficient of Variation 125	6780 ng/mL Geometric Coefficient of Variation 100	6400 ng/mL Geometric Coefficient of Variation 123	5980 ng/mL Geometric Coefficient of Variation 91.2	46300 ng/mL Geometric Coefficient of Variation 58.7	—
Trough Concentration (Cpre,ss) of Faldaprevir at Steady State week 24(N=47,86,95,78,39,26)	1170 ng/mL Geometric Coefficient of Variation 142	6440 ng/mL Geometric Coefficient of Variation 109	6610 ng/mL Geometric Coefficient of Variation 132	6630 ng/mL Geometric Coefficient of Variation 102	4280 ng/mL Geometric Coefficient of Variation 179	33900 ng/mL Geometric Coefficient of Variation 509	—

SECONDARY outcome

Timeframe: Week 8, week 10, week 12, week 24

C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=143 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=146 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1000 mg/Day RBV) week 8(N=23,25,46,43,38,20,12)	2260 ng/mL Geometric Coefficient of Variation 26.6	1920 ng/mL Geometric Coefficient of Variation 37.9	2320 ng/mL Geometric Coefficient of Variation 30.8	2200 ng/mL Geometric Coefficient of Variation 28.7	2150 ng/mL Geometric Coefficient of Variation 26.4	2090 ng/mL Geometric Coefficient of Variation 26.0	2180 ng/mL Geometric Coefficient of Variation 27.1
Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1000 mg/Day RBV) week 10(N=22,27,50,38,34,25,11)	2210 ng/mL Geometric Coefficient of Variation 28.2	1960 ng/mL Geometric Coefficient of Variation 33.3	2290 ng/mL Geometric Coefficient of Variation 30.8	2330 ng/mL Geometric Coefficient of Variation 23.8	2190 ng/mL Geometric Coefficient of Variation 28.9	2140 ng/mL Geometric Coefficient of Variation 24.6	2300 ng/mL Geometric Coefficient of Variation 21.5
Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1000 mg/Day RBV) week 12(N=22,27,45,47,37,21,11)	2200 ng/mL Geometric Coefficient of Variation 25.1	2060 ng/mL Geometric Coefficient of Variation 35.9	2290 ng/mL Geometric Coefficient of Variation 33.6	2340 ng/mL Geometric Coefficient of Variation 29.5	2140 ng/mL Geometric Coefficient of Variation 28.2	2150 ng/mL Geometric Coefficient of Variation 23.6	2300 ng/mL Geometric Coefficient of Variation 27.3
Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1000 mg/Day RBV) week 24(N=21,18,37,34,28,16,11)	2370 ng/mL Geometric Coefficient of Variation 34.6	2100 ng/mL Geometric Coefficient of Variation 45.3	2390 ng/mL Geometric Coefficient of Variation 29.6	2260 ng/mL Geometric Coefficient of Variation 37.3	1960 ng/mL Geometric Coefficient of Variation 35.5	2270 ng/mL Geometric Coefficient of Variation 25.0	1970 ng/mL Geometric Coefficient of Variation 47.1

SECONDARY outcome

Timeframe: Week 8, week 10, week 12, week 24

C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=143 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=146 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1200 mg/Day RBV) week 8(N=24,21,45,48,49,25,23)	1670 ng/mL Geometric Coefficient of Variation 118	2010 ng/mL Geometric Coefficient of Variation 30.4	2060 ng/mL Geometric Coefficient of Variation 26.5	2170 ng/mL Geometric Coefficient of Variation 30.4	2060 ng/mL Geometric Coefficient of Variation 30.5	2170 ng/mL Geometric Coefficient of Variation 40.2	1880 ng/mL Geometric Coefficient of Variation 37.2
Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1200 mg/Day RBV) week 10(N=27,22,43,45,47,22,22)	1780 ng/mL Geometric Coefficient of Variation 97.3	1970 ng/mL Geometric Coefficient of Variation 28.5	2100 ng/mL Geometric Coefficient of Variation 26.1	2280 ng/mL Geometric Coefficient of Variation 26.5	2090 ng/mL Geometric Coefficient of Variation 30.5	1980 ng/mL Geometric Coefficient of Variation 35.3	2090 ng/mL Geometric Coefficient of Variation 34.4
Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1200 mg/Day RBV) week 12(N=27,21,46,47,44,25,22)	1880 ng/mL Geometric Coefficient of Variation 59.1	1900 ng/mL Geometric Coefficient of Variation 37.0	2090 ng/mL Geometric Coefficient of Variation 21.7	2260 ng/mL Geometric Coefficient of Variation 26.0	2190 ng/mL Geometric Coefficient of Variation 29.0	2010 ng/mL Geometric Coefficient of Variation 33.2	1950 ng/mL Geometric Coefficient of Variation 24.9
Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1200 mg/Day RBV) week 24(N=21,19,33,39,38,18,17)	2030 ng/mL Geometric Coefficient of Variation 27.0	2390 ng/mL Geometric Coefficient of Variation 23.3	1970 ng/mL Geometric Coefficient of Variation 32.2	2250 ng/mL Geometric Coefficient of Variation 23.0	2180 ng/mL Geometric Coefficient of Variation 27.7	2050 ng/mL Geometric Coefficient of Variation 31.9	2220 ng/mL Geometric Coefficient of Variation 29.7

SECONDARY outcome

Timeframe: Week 8, week 10, week 12, week 24

C(pre,ss) is defined as pre-dose (trough) concentration of PegIFN in plasma at steady state immediately before administration of the next dose.

Outcome measures

Outcome measures
Measure	Placebo-TN n=71 Participants Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120 mg QD / LI-TN n=69 Participants 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TN n=143 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TN n=146 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD / LI-TE n=142 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg QD-TE n=76 Participants 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240 mg BID / LI-TE n=70 Participants 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Trough Concentration (Cpre,ss) of PegIFN at Steady State week 24(N=49,42,74,87,75,40,38)	17300 ng/mL Geometric Coefficient of Variation 45.4	17200 ng/mL Geometric Coefficient of Variation 83.8	16900 ng/mL Geometric Coefficient of Variation 42.2	16700 ng/mL Geometric Coefficient of Variation 50.3	15600 ng/mL Geometric Coefficient of Variation 44.0	15300 ng/mL Geometric Coefficient of Variation 63.3	15700 ng/mL Geometric Coefficient of Variation 38.5
Trough Concentration (Cpre,ss) of PegIFN at Steady State week 8(N=55,46,80,91,80,36,33)	14500 ng/mL Geometric Coefficient of Variation 83.9	14800 ng/mL Geometric Coefficient of Variation 59.9	14900 ng/mL Geometric Coefficient of Variation 41.1	15100 ng/mL Geometric Coefficient of Variation 58.5	11300 ng/mL Geometric Coefficient of Variation 151	11100 ng/mL Geometric Coefficient of Variation 125	12300 ng/mL Geometric Coefficient of Variation 95.1
Trough Concentration (Cpre,ss) of PegIFN at Steady State week 10(N=46,48,88,94,80,40,33)	14700 ng/mL Geometric Coefficient of Variation 86.6	13400 ng/mL Geometric Coefficient of Variation 87.1	14600 ng/mL Geometric Coefficient of Variation 70.2	15500 ng/mL Geometric Coefficient of Variation 52.2	11300 ng/mL Geometric Coefficient of Variation 144	11600 ng/mL Geometric Coefficient of Variation 155	12500 ng/mL Geometric Coefficient of Variation 85.4
Trough Concentration (Cpre,ss) of PegIFN at Steady State week 12(N=54,51,100,107,105,56,42)	15600 ng/mL Geometric Coefficient of Variation 77.9	13000 ng/mL Geometric Coefficient of Variation 102	13700 ng/mL Geometric Coefficient of Variation 89.4	14600 ng/mL Geometric Coefficient of Variation 70.5	13100 ng/mL Geometric Coefficient of Variation 105	13800 ng/mL Geometric Coefficient of Variation 110	13500 ng/mL Geometric Coefficient of Variation 102

Adverse Events

Placebo-TN

Serious events: 2 serious events

Other events: 65 other events

Deaths: 0 deaths

120mg QD/LI-TN

Serious events: 3 serious events

Other events: 65 other events

Deaths: 0 deaths

240mg QD/LI-TN

Serious events: 18 serious events

Other events: 135 other events

Deaths: 0 deaths

240mg QD-TN

Serious events: 12 serious events

Other events: 143 other events

Deaths: 0 deaths

240mg QD/LI-TE

Serious events: 10 serious events

Other events: 135 other events

Deaths: 0 deaths

240mg QD-TE

Serious events: 5 serious events

Other events: 74 other events

Deaths: 0 deaths

240mg BID/LI-TE

Serious events: 13 serious events

Other events: 68 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo-TN n=71 participants at risk Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120mg QD/LI-TN n=68 participants at risk 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240mg QD/LI-TN n=138 participants at risk 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240mg QD-TN n=149 participants at risk 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240mg QD/LI-TE n=141 participants at risk 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240mg QD-TE n=76 participants at risk 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240mg BID/LI-TE n=69 participants at risk 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Immune system disorders Cryoglobulinaemia	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.71% 1/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Blood and lymphatic system disorders Anaemia	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.71% 1/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.3% 3/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Blood and lymphatic system disorders Anaemia haemolytic autoimmune	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.71% 1/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.67% 1/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.5% 1/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.67% 1/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Cardiac disorders Angina pectoris	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Cardiac disorders Microvascular angina	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Cardiac disorders Myocardial infarction	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Cardiac disorders Prinzmetal angina	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.5% 1/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations Anal abscess	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Eye disorders Cataract	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.67% 1/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Eye disorders Photophobia	1.4% 1/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Anal fistula	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.71% 1/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Diarrhoea	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Haemorrhoids	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Mouth ulceration	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Nausea	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.67% 1/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.71% 1/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Vomiting	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.9% 2/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
General disorders Asthenia	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
General disorders Chest discomfort	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
General disorders Chest pain	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
General disorders Cyst	1.4% 1/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
General disorders Fatigue	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
General disorders Mucosal inflammation	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
General disorders Oedema peripheral	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
General disorders Pyrexia	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 2/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.67% 1/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.71% 1/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Hepatobiliary disorders Cholecystitis	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Hepatobiliary disorders Gallbladder polyp	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations Ear infection	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations H1N1 influenza	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.71% 1/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations Infected skin ulcer	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations Influenza	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations Lower respiratory tract infection	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations Lymphangitis	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations Oral herpes	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations Perirectal abscess	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations Pharyngitis	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations Pneumonia	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.67% 1/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations Pyelonephritis	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.71% 1/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations Subcutaneous abscess	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations Superinfection bacterial	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.67% 1/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations Upper respiratory tract infection	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations Urinary tract infection	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.71% 1/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Metabolism and nutrition disorders Dehydration	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.67% 1/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	1.4% 1/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Nervous system disorders Headache	1.4% 1/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Nervous system disorders Ischaemic stroke	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Nervous system disorders Migraine	1.4% 1/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Nervous system disorders Syncope	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.5% 1/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.71% 1/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Psychiatric disorders Acute psychosis	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Psychiatric disorders Depressed mood	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Psychiatric disorders Depression	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.67% 1/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Psychiatric disorders Suicide attempt	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.71% 1/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Renal and urinary disorders Calculus ureteric	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.67% 1/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 2/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.67% 1/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Lichen planus	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.67% 1/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Parapsoriasis	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.67% 1/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Pruritus allergic	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Rash	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Surgical and medical procedures Appendicectomy	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.

Other adverse events

Other adverse events
Measure	Placebo-TN n=71 participants at risk Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	120mg QD/LI-TN n=68 participants at risk 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240mg QD/LI-TN n=138 participants at risk 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240mg QD-TN n=149 participants at risk 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240mg QD/LI-TE n=141 participants at risk 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240mg QD-TE n=76 participants at risk 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]	240mg BID/LI-TE n=69 participants at risk 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients \[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)\]
Skin and subcutaneous tissue disorders Alopecia	11.3% 8/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	23.5% 16/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	21.0% 29/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	15.4% 23/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	12.1% 17/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	11.8% 9/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	17.4% 12/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Dry skin	14.1% 10/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	23.5% 16/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	18.1% 25/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	14.8% 22/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	18.4% 26/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	17.1% 13/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	29.0% 20/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Blood and lymphatic system disorders Anaemia	16.9% 12/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	20.6% 14/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	11.6% 16/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	14.8% 22/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.1% 10/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	13.2% 10/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	18.8% 13/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Blood and lymphatic system disorders Neutropenia	11.3% 8/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	13.2% 9/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	8.0% 11/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.0% 9/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.0% 7/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	13.2% 10/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.3% 3/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Eye disorders Dry eye	2.8% 2/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.5% 1/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.1% 7/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.7% 4/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.7% 8/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	3.9% 3/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.3% 3/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Eye disorders Ocular icterus	1.4% 1/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.5% 1/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.8% 8/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 2/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 2/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	10.5% 8/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	8.7% 6/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Eye disorders Vision blurred	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.9% 2/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.9% 4/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 2/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.0% 7/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Abdominal discomfort	2.8% 2/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.5% 1/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.7% 7/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.1% 10/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Abdominal distension	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.5% 1/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 2/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.7% 10/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.71% 1/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Constipation	1.4% 1/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.4% 5/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.3% 6/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.0% 3/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.0% 7/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.6% 2/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	8.7% 6/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Abdominal pain	8.5% 6/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.9% 4/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.5% 9/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.0% 6/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.1% 10/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.9% 2/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Abdominal pain upper	4.2% 3/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	8.8% 6/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.5% 9/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	9.4% 14/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.8% 11/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	13.2% 10/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	15.9% 11/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Cheilitis	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.5% 1/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	3.4% 5/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.1% 3/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.2% 5/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Diarrhoea	18.3% 13/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	13.2% 9/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	31.9% 44/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	26.8% 40/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	31.9% 45/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	31.6% 24/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	37.7% 26/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Dry mouth	2.8% 2/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.4% 3/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.1% 7/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.0% 9/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.1% 10/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.3% 3/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Nausea	19.7% 14/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	25.0% 17/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	47.1% 65/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	44.3% 66/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	48.2% 68/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	52.6% 40/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	62.3% 43/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Dyspepsia	5.6% 4/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.4% 3/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	13.0% 18/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	8.7% 13/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.1% 10/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.6% 5/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	11.6% 8/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.8% 2/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.9% 2/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.9% 4/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.67% 1/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.3% 6/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.8% 4/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Toothache	1.4% 1/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.9% 4/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 2/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	3.4% 5/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	3.9% 3/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Gastrointestinal disorders Vomiting	5.6% 4/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	20.6% 14/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	18.1% 25/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	22.8% 34/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	17.0% 24/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	22.4% 17/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	30.4% 21/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
General disorders Asthenia	21.1% 15/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	14.7% 10/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	23.9% 33/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	27.5% 41/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	24.1% 34/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	19.7% 15/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	27.5% 19/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
General disorders Chills	11.3% 8/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.9% 4/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	10.1% 14/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	10.7% 16/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.1% 10/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	11.8% 9/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
General disorders Fatigue	33.8% 24/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	27.9% 19/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	23.2% 32/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	26.2% 39/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	34.8% 49/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	39.5% 30/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	36.2% 25/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
General disorders Influenza like illness	47.9% 34/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	38.2% 26/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	34.8% 48/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	36.9% 55/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	31.2% 44/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	27.6% 21/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	33.3% 23/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
General disorders Injection site erythema	9.9% 7/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.4% 3/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.1% 7/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.0% 9/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.7% 8/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.3% 3/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
General disorders Irritability	14.1% 10/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	11.8% 8/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	10.9% 15/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	8.7% 13/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	19.1% 27/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	15.8% 12/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	10.1% 7/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
General disorders Pyrexia	15.5% 11/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	14.7% 10/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	18.8% 26/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	20.1% 30/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	17.7% 25/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	15.8% 12/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	23.2% 16/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.4% 3/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	9.4% 13/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.0% 3/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 2/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.3% 4/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations Herpes simplex	5.6% 4/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.5% 1/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.67% 1/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.71% 1/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Hepatobiliary disorders Jaundice	1.4% 1/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.9% 4/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	19.6% 27/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	24.8% 37/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	17.7% 25/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	13.2% 10/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	37.7% 26/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Infections and infestations Influenza	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.9% 4/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.9% 4/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.0% 6/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.8% 4/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.2% 5/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Injury, poisoning and procedural complications Sunburn	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.5% 1/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.2% 3/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.7% 7/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.3% 6/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.6% 2/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.2% 5/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Investigations Blood bilirubin increased	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.67% 1/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 2/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.6% 2/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.8% 4/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Investigations Haemoglobin decreased	5.6% 4/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.9% 2/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.0% 6/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.1% 3/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.6% 2/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Investigations Weight decreased	5.6% 4/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.4% 3/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.5% 9/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.7% 10/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.0% 7/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.6% 5/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	10.1% 7/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Metabolism and nutrition disorders Decreased appetite	15.5% 11/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	23.5% 16/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	20.3% 28/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	20.8% 31/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	19.9% 28/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	18.4% 14/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	23.2% 16/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Musculoskeletal and connective tissue disorders Arthralgia	7.0% 5/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	16.2% 11/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	10.9% 15/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	10.7% 16/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	9.2% 13/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	14.5% 11/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	8.7% 6/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Musculoskeletal and connective tissue disorders Back pain	4.2% 3/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	8.8% 6/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.2% 10/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.7% 7/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	8.5% 12/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.6% 2/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.8% 4/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.4% 5/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.7% 4/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.71% 1/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.9% 2/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.3% 6/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.0% 6/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.4% 9/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.9% 6/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.3% 3/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Musculoskeletal and connective tissue disorders Myalgia	16.9% 12/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	20.6% 14/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	18.8% 26/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	23.5% 35/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	17.0% 24/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	22.4% 17/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	24.6% 17/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Eczema	4.2% 3/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.9% 4/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.5% 9/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.7% 7/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.8% 4/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.6% 5/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.8% 4/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Musculoskeletal and connective tissue disorders Neck pain	1.4% 1/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 2/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.0% 3/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.71% 1/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	3.9% 3/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.8% 4/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Musculoskeletal and connective tissue disorders Pain in extremity	1.4% 1/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.9% 4/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.2% 3/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.7% 4/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 2/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.9% 2/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Nervous system disorders Disturbance in attention	4.2% 3/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.9% 2/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	3.6% 5/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 2/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.7% 8/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	3.9% 3/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.3% 3/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Nervous system disorders Dizziness	7.0% 5/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.9% 4/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.5% 9/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.7% 10/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	11.3% 16/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.3% 4/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.2% 5/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Nervous system disorders Dysgeusia	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.4% 3/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.9% 4/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 2/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.7% 8/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	3.9% 3/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.2% 5/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Nervous system disorders Headache	38.0% 27/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	41.2% 28/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	33.3% 46/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	34.2% 51/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	39.7% 56/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	42.1% 32/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	43.5% 30/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Nervous system disorders Lethargy	7.0% 5/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.4% 3/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	3.6% 5/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.0% 3/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 2/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Nervous system disorders Paraesthesia	2.8% 2/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.5% 1/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 2/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.1% 3/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.8% 4/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Psychiatric disorders Anxiety	4.2% 3/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.4% 3/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	3.6% 5/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.0% 6/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.8% 11/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.3% 4/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.9% 2/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Psychiatric disorders Depressed mood	4.2% 3/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 2/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.0% 3/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.3% 6/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.6% 2/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.2% 5/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Psychiatric disorders Depression	9.9% 7/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	13.2% 9/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	11.6% 16/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	11.4% 17/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	13.5% 19/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	3.9% 3/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.8% 4/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Psychiatric disorders Insomnia	23.9% 17/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	17.6% 12/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	15.9% 22/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	18.8% 28/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	21.3% 30/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	15.8% 12/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	20.3% 14/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Psychiatric disorders Mood swings	7.0% 5/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.5% 1/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 2/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.0% 3/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.71% 1/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.6% 5/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.4% 1/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Psychiatric disorders Sleep disorder	4.2% 3/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.4% 3/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	11.6% 16/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	8.1% 12/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.4% 9/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	10.5% 8/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	8.7% 6/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Respiratory, thoracic and mediastinal disorders Cough	12.7% 9/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	13.2% 9/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	15.9% 22/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	12.1% 18/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	17.7% 25/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	17.1% 13/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	18.8% 13/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.5% 11/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	13.2% 9/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	9.4% 13/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	8.7% 13/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	17.0% 24/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	9.2% 7/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	10.1% 7/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	4.2% 3/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.8% 8/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.4% 8/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.3% 6/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.6% 2/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	2.9% 2/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.8% 8/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	6.0% 9/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	4.3% 6/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	7.9% 6/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.8% 4/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.9% 4/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.72% 1/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.67% 1/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	5.0% 7/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.3% 1/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	0.00% 0/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Photosensitivity reaction	1.4% 1/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	1.5% 1/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	9.4% 13/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	9.4% 14/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	13.5% 19/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	13.2% 10/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	27.5% 19/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Pruritus	16.9% 12/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	32.4% 22/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	35.5% 49/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	37.6% 56/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	30.5% 43/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	44.7% 34/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	33.3% 23/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
Skin and subcutaneous tissue disorders Rash	16.9% 12/71 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	20.6% 14/68 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	28.3% 39/138 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	26.8% 40/149 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	24.8% 35/141 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	18.4% 14/76 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.	30.4% 21/69 • Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120. In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.

Additional Information

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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.
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