Trial Outcomes & Findings for Phase I Trial of BI 836845 for Various Solid Cancer (NCT NCT01403974)

Last Updated: 2025-07-25

Results Overview

In the absence of MTD, the relevant biological dose (RBD) of BI 836845 during the first treatment course of the dose escalation phase was reported. The MTD was defined as the highest dose level of BI 836845 at which no more than 1 out of 6 patients experienced a drug related dose limiting toxicity (DLT) during the first course of treatment. Starting dose of 10 milligrams (mg) BI 836845, administered thrice every 3 weeks. Dose levels evaluated were: 10 mg, 20 mg, 40 mg, 60 mg, 90 mg, 135 mg, 200 mg, 300 mg, 450 mg, 600 mg, 800 mg, 1050 mg, 1400 mg and 1800 mg. The BI 836845 dose which could achieve a plateau in total Insulin-like growth factor 1 (IGF-1) plasma concentrations was considered the RBD.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

61 participants

Primary outcome timeframe

During the first course of treatment, up to 21 days

Results posted on

2025-07-25

Participant Flow

Part 1: dose escalation in patients with advanced solid tumours to determine maximum tolerated dose (MTD) or relevant biological dose (RBD); Part 2: expansion part at the RBD in patients with selected tumour types (Cohort 1- Ewing's sarcoma family of tumours; Cohort 2 - biopsiable solid tumours) in order to investigate safety and pharmacokinetics.

All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were to be entered to trial drug if any of the specific entry criteria was violated.

Participant milestones

Participant milestones
Measure	Part 1: BI 836845 10 mg Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 20 mg Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 40 mg Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 60 mg Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 90 mg Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 135 mg Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 200 mg Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 300 mg Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 450 mg Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 600 mg Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 800 mg Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1050 mg Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1400 mg Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1800 mg Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 2: Ewing's Sarcoma Family of Tumours Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study	Part 2: Biopsiable Tumours Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Overall Study STARTED	3	3	3	3	3	3	3	3	8	3	4	3	3	3	1	12
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	3	3	3	3	3	3	3	8	3	4	3	3	3	1	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: BI 836845 10 mg Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 20 mg Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 40 mg Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 60 mg Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 90 mg Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 135 mg Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 200 mg Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 300 mg Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 450 mg Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 600 mg Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 800 mg Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1050 mg Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1400 mg Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1800 mg Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 2: Ewing's Sarcoma Family of Tumours Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study	Part 2: Biopsiable Tumours Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Overall Study Progressive disease according to RECIST	3	3	2	3	3	2	3	2	6	2	3	2	2	3	1	8
Overall Study Dose limiting toxicity (DLT)	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Overall Study Refused to continue study medication	0	0	0	0	0	1	0	0	1	0	1	0	0	0	0	4
Overall Study Adverse Event	0	0	1	0	0	0	0	1	0	0	0	0	1	0	0	0
Overall Study Other than specified	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0

Baseline Characteristics

Phase I Trial of BI 836845 for Various Solid Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: BI 836845 10 mg n=3 Participants Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 60 mg n=3 Participants Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 90 mg n=3 Participants Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 135 mg n=3 Participants Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 200 mg n=3 Participants Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 300 mg n=3 Participants Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 450 mg n=8 Participants Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 600 mg n=3 Participants Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 800 mg n=4 Participants Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1050 mg n=3 Participants Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1400 mg n=3 Participants Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 2: Ewing's Sarcoma Family of Tumours n=1 Participants Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study	Part 2: Biopsiable Tumours n=12 Participants Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study	Total n=61 Participants Total of all reporting groups
Race/Ethnicity, Customized Asian - other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	6 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=36 Participants	3 Participants n=36 Participants	1 Participants n=24 Participants	8 Participants n=135 Participants	50 Participants n=136 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	4 Participants n=135 Participants	11 Participants n=136 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	9 Participants n=135 Participants	23 Participants n=136 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants	3 Participants n=24 Participants	6 Participants n=42 Participants	2 Participants n=42 Participants	4 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=36 Participants	3 Participants n=36 Participants	1 Participants n=24 Participants	3 Participants n=135 Participants	38 Participants n=136 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	8 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants	3 Participants n=42 Participants	3 Participants n=36 Participants	3 Participants n=36 Participants	1 Participants n=24 Participants	12 Participants n=135 Participants	61 Participants n=136 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants
Race/Ethnicity, Customized Indian subcontinent Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants
Race/Ethnicity, Customized Southeast Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants
Race/Ethnicity, Customized Japanese	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants
Race/Ethnicity, Customized Korean	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants
Race/Ethnicity, Customized Taiwanese or Chinese	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	8 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants	3 Participants n=42 Participants	3 Participants n=36 Participants	3 Participants n=36 Participants	1 Participants n=24 Participants	12 Participants n=135 Participants	61 Participants n=136 Participants

PRIMARY outcome

Timeframe: During the first course of treatment, up to 21 days

Population: Treated set (TS) restricted to the part 1 (dose escalation) of the trial: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment in the dose escalation part of the trial.

Outcome measures

Outcome measures
Measure	Part 1: BI 836845 n=48 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	Part 1: BI 836845 20 mg Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 40 mg Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 60 mg Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 90 mg Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 135 mg Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 200 mg Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 300 mg Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 450 mg Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 600 mg Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 800 mg Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1050 mg Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1400 mg Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1800 mg Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 2: Ewing's Sarcoma Family of Tumours Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study	Part 2: Biopsiable Tumours Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Part 1: Maximum Tolerated Dose (MTD) of BI 836845 During the First Treatment Course of the Dose Escalation Phase.	1000 milligram (mg)	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: During the first course of treatment, up to 21 days

Population: TS restricted to the part 1 (dose escalation) of the trial: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment in the dose escalation part of the trial. Three patients (two patients at the 450 mg and one patient at 800 mg) were replaced thus not included in the analysis of primary endpoint.

Number of participants with DLTs occurring during the first treatment course of the dose escalation part. DLT was defined as drug-related adverse events meeting the criteria summarized below: * Common terminology criteria for adverse events (CTCAE) grade 4 neutropenia for ≥ 7 days (d) * Febrile neutropenia with single temperature of \> 38.3°C/ ≥ 38°C more than 1 hour (h) * Documented infection with high neutrophile count * CTCAE grade 4 thrombocytopenia/CTCAE grade 3 thrombocytopenia associated with bleeding requiring transfusion * AST (Aspartate Amino Transferase)/ALT (Alanine Amino Transferase) \> 5x normal * CTCAE grade 3/4 non-hematologic toxicity * CTCAE grade ≥2 infusion reaction * CTCAE grade ≥2 nausea and/or vomiting for ≥7 d * CTCAE grade ≥3 skin toxicity * CTCAE grade ≥3 hyperglycemia * Any electrolyte grade 3 AE * No recovery from non-DLT CTCAE grade \>2 * Sustained fatigue/asthenia grade 3 for longer than 96 h * Other event qualified as DLT by the investigator

Outcome measures

Outcome measures
Measure	Part 1: BI 836845 n=3 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	Part 1: BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 60 mg n=3 Participants Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 90 mg n=3 Participants Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 135 mg n=3 Participants Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 200 mg n=3 Participants Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 300 mg n=3 Participants Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 450 mg n=8 Participants Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 600 mg n=3 Participants Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 800 mg n=4 Participants Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1050 mg n=3 Participants Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1400 mg n=3 Participants Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 2: Ewing's Sarcoma Family of Tumours Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study	Part 2: Biopsiable Tumours Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Part 1: Number of Patients With Dose Limiting Toxicities (DLTs) During the Maximum Tolerated Dose (MTD) Evaluation Period	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: First treatment administration until the earliest of disease progression, death, last adequate tumor assessment or the start of subsequent anti-cancer therapy. Up to 72 weeks.

Population: Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.

Number of patients with the objective response (OR). Objective response was defined as best overall response of complete response (CR) or partial response (PR) (with no confirmation required) based on Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. CR was defined by the disappearance of all target lesions and PR was defined by a decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. The best overall response was recorded since first administration of the trial medication and until the earliest of disease progression, death, last adequate tumor assessment or the start of subsequent anti-cancer therapy.

Outcome measures

Outcome measures
Measure	Part 1: BI 836845 n=3 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	Part 1: BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 60 mg n=3 Participants Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 90 mg n=3 Participants Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 135 mg n=3 Participants Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 200 mg n=3 Participants Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 300 mg n=3 Participants Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 450 mg n=8 Participants Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 600 mg n=3 Participants Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 800 mg n=4 Participants Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1050 mg n=3 Participants Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1400 mg n=3 Participants Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 2: Ewing's Sarcoma Family of Tumours n=1 Participants Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study	Part 2: Biopsiable Tumours n=12 Participants Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Objective Tumour Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: First treatment administration until the earliest of disease progression, death, last adequate tumor assessment or the start of subsequent anti-cancer therapy. Up to 72 weeks.

Population: Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. Only two subjects experienced event or were eligible for censoring.

Duration of objective response (days), defined as time from first objective response to the time to progression or death and was only calculated for patients with an objective response (with no confirmation required).

Outcome measures

Outcome measures
Measure	Part 1: BI 836845 BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	Part 1: BI 836845 20 mg Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 40 mg Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 60 mg Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 90 mg Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 135 mg Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 200 mg Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 300 mg Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 450 mg Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 600 mg Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 800 mg n=1 Participants Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1050 mg n=1 Participants Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1400 mg Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1800 mg Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 2: Ewing's Sarcoma Family of Tumours Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study	Part 2: Biopsiable Tumours Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Duration of Objective Response	—	—	—	—	—	—	—	—	—	—	145 days Only one subject reported OR in this dose group, hence actual duration is presented without confidence interval.	213 days Only one subject reported OR in this dose group, hence actual duration is presented without confidence interval.	—	—	—	—

SECONDARY outcome

Timeframe: First treatment administration until disease progression or last evaluable assessment in absence of progression; Up to 72 weeks

Population: Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.

Number of patients with best overall response. Best overall response represented the best response (complete response - CR, partial response - PR, stable disease -SD, progressive disease - PD) a patient had during their time in the study from first administration of trial medication until the earliest date of progression, or the last evaluable assessment in the absence of progression or the start of subsequent anti-cancer therapy. CR was defined by the disappearance of all target lesions and PR was defined by a decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Outcome measures

Outcome measures
Measure	Part 1: BI 836845 n=3 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	Part 1: BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 60 mg n=3 Participants Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 90 mg n=3 Participants Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 135 mg n=3 Participants Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 200 mg n=3 Participants Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 300 mg n=3 Participants Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 450 mg n=8 Participants Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 600 mg n=3 Participants Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 800 mg n=4 Participants Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1050 mg n=3 Participants Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1400 mg n=3 Participants Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 2: Ewing's Sarcoma Family of Tumours n=1 Participants Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study	Part 2: Biopsiable Tumours n=12 Participants Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Best Overall Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Criteria Version 1.1 SD	2 Participants	1 Participants	2 Participants	2 Participants	2 Participants	0 Participants	2 Participants	1 Participants	3 Participants	3 Participants	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants	7 Participants
Best Overall Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Criteria Version 1.1 SD≥24 weeks	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants
Best Overall Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Criteria Version 1.1 CR	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Best Overall Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Criteria Version 1.1 PR	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Best Overall Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Criteria Version 1.1 PD	1 Participants	2 Participants	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants	2 Participants	3 Participants	0 Participants	1 Participants	2 Participants	2 Participants	2 Participants	0 Participants	3 Participants
Best Overall Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Criteria Version 1.1 Not evaluable	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: First treatment administration until the earliest of disease progression, death, last adequate tumor assessment or the start of subsequent anti-cancer therapy. Up to 72 weeks.

Population: Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.

Number of patients with Disease control. Disease control was defined as best overall response of CR, PR or SD \>24 week, with no confirmation required.

Outcome measures

Outcome measures
Measure	Part 1: BI 836845 n=3 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	Part 1: BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 60 mg n=3 Participants Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 90 mg n=3 Participants Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 135 mg n=3 Participants Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 200 mg n=3 Participants Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 300 mg n=3 Participants Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 450 mg n=8 Participants Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 600 mg n=3 Participants Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 800 mg n=4 Participants Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1050 mg n=3 Participants Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1400 mg n=3 Participants Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 2: Ewing's Sarcoma Family of Tumours n=1 Participants Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study	Part 2: Biopsiable Tumours n=12 Participants Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Disease Control	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: First treatment administration until tumour progression or death. Up to 72 weeks

Population: TS restricted to the part 2 - biopsiable tumours cohort (dose expansion) of the trial: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment in the biopsiable tumours cohort of the dose escalation part of the trial.

PFS was evaluated only for cohort 2 (Biopsiable tumors) in expansion phase of the study. PFS was defined as the time from first treatment administration until tumour progression according to RECIST 1.1 or death from any cause, whichever occurred earlier. Median duration along with 95% confidence interval is based on Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Part 1: BI 836845 n=12 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	Part 1: BI 836845 20 mg Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 40 mg Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 60 mg Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 90 mg Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 135 mg Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 200 mg Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 300 mg Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 450 mg Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 600 mg Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 800 mg Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1050 mg Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1400 mg Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1800 mg Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 2: Ewing's Sarcoma Family of Tumours Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study	Part 2: Biopsiable Tumours Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Part 2 - Biopsiable Tumours: Progression-free Survival (PFS)	118.0 days Interval 18.0 to 504.0	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 337 hours. Detailed timeframe is in the description.

Population: Pharmacokinetic (PK) set: All patients in the treated set who were documented to have received at least one dose of BI 836845 and who had at least one valid PK parameter concentration available. Participants with no available blood samples were excluded from the analysis.

Maximum measured concentration of the BI 836845 in plasma (Cmax). Geometric mean (gMean) and Geometric coefficient of variation (gCV) is presented for each course. As defined in the CTP, PK data is presented by BI 836845 dose level and was not collected for Course 4 part 2. For Course 1 of part 1 and part 2, Course 2 part 1 and part 2, Course 3 part 2, Course 4 part 1 the following timeframe applies : At 0.083 hour before and 0.5, 1, 2, 4, 7, 24, 72\*, 168, 169, 336 and 337 hours after infusion. \* applies only to part 1 administration courses. In Course 3 of part 1 the following timeframe applies: At 0.083 hour before and 0.5, 1, 168, 169, 336 and 337 hours after infusion.

Outcome measures

Outcome measures
Measure	Part 1: BI 836845 n=3 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	Part 1: BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 60 mg n=3 Participants Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 90 mg n=3 Participants Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 135 mg n=3 Participants Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 200 mg n=3 Participants Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 300 mg n=3 Participants Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 450 mg n=8 Participants Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 600 mg n=3 Participants Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 800 mg n=4 Participants Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1050 mg n=3 Participants Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1400 mg n=3 Participants Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 2: Ewing's Sarcoma Family of Tumours n=13 Participants Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study	Part 2: Biopsiable Tumours Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Maximum Measured Concentration of the BI 836845 in Plasma (Cmax) Course 4	3.96 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 53.9	5.27 microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	18.8 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 1.88	28.5 microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	39.6 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 15.2	—	86.8 microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	—	201 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 10.9	279 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 28.6	253 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 36.3	615 microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	612 microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	739 microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	—	—
Maximum Measured Concentration of the BI 836845 in Plasma (Cmax) Course 1	2.87 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 23.8	6.53 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 14.9	13.8 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 26.6	22.2 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 3.78	28.2 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 28.7	36.6 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 20.6	70.8 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 26.7	81.9 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 42.2	151 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 16.7	199 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 10.8	200 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 38.1	270 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 38.9	415 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 13.0	503 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 13.4	386 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 30.7	—
Maximum Measured Concentration of the BI 836845 in Plasma (Cmax) Course 2	3.34 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 31.9	7.92 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 24.8	22.4 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 23.9	26.9 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 17.1	36.6 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 19.4	55.2 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 29.8	99.2 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 28.5	100 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 21.8	193 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 18.0	285 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 11.7	282 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 40.3	393 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 39.1	559 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 6.46	732 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 5.57	607 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 10.4	—
Maximum Measured Concentration of the BI 836845 in Plasma (Cmax) Course 3	NA microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram per milliliter (µg/ml) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	616 microgram per milliliter (µg/ml) Geometric Coefficient of Variation 24.8	—

SECONDARY outcome

Timeframe: Up to 337 hours. Detailed timeframe is in the description.

Time to maximum measured concentration of the BI 836845 in plasma (tmax). As defined in the CTP, PK data is presented by BI 836845 dose level and was not collected for Course 4 part 2. For Course 1 of part 1 and part 2, Course 2 part 1 and part 2, Course 3 part 2, Course 4 part 1 the following timeframe applies : At 0.083 hour before and 0.5, 1, 2, 4, 7, 24, 72\*, 168, 169, 336 and 337 hours after infusion. \* applies only to part 1 administration courses. In Course 3 of part 1 the following timeframe applies: At 0.083 hour before and 0.5, 1, 168, 169, 336 and 337 hours after infusion.

Outcome measures

Outcome measures
Measure	Part 1: BI 836845 n=3 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	Part 1: BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 60 mg n=3 Participants Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 90 mg n=3 Participants Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 135 mg n=3 Participants Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 200 mg n=3 Participants Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 300 mg n=3 Participants Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 450 mg n=8 Participants Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 600 mg n=3 Participants Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 800 mg n=4 Participants Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1050 mg n=3 Participants Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1400 mg n=3 Participants Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 2: Ewing's Sarcoma Family of Tumours n=13 Participants Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study	Part 2: Biopsiable Tumours Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Time to Maximum Measured Concentration BI 836845 in Plasma (Tmax) Course 1	2.10 hours Interval 1.15 to 4.0	2.02 hours Interval 1.75 to 6.38	2.03 hours Interval 2.0 to 2.03	1.13 hours Interval 1.03 to 1.92	2.00 hours Interval 1.8 to 7.0	1.05 hours Interval 1.03 to 1.92	2.00 hours Interval 2.0 to 3.77	2.25 hours Interval 2.07 to 2.28	1.18 hours Interval 1.02 to 7.0	2.00 hours Interval 1.92 to 2.25	1.25 hours Interval 1.07 to 2.0	1.17 hours Interval 1.02 to 4.02	2.00 hours Interval 1.0 to 2.0	2.00 hours Interval 1.0 to 2.0	4.00 hours Interval 1.0 to 7.0	—
Time to Maximum Measured Concentration BI 836845 in Plasma (Tmax) Course 2	0.967 hours Interval 0.967 to 2.03	7.00 hours Interval 0.967 to 24.1	1.50 hours Interval 1.0 to 2.0	2.00 hours Interval 0.983 to 2.0	2.15 hours Interval 1.0 to 4.0	2.89 hours Interval 1.03 to 4.75	2.97 hours Interval 2.0 to 7.0	1.45 hours Interval 1.05 to 2.02	1.12 hours Interval 1.05 to 2.02	2.07 hours Interval 1.12 to 5.95	1.83 hours Interval 1.4 to 2.0	4.00 hours Interval 3.95 to 4.0	1.00 hours Interval 1.0 to 2.0	2.00 hours Interval 1.0 to 4.0	2.00 hours Interval 1.0 to 24.0	—
Time to Maximum Measured Concentration BI 836845 in Plasma (Tmax) Course 3	NA hours Not evaluable due to sparse sampling.	NA hours Not evaluable due to sparse sampling.	NA hours Not evaluable due to sparse sampling.	NA hours Not evaluable due to sparse sampling.	NA hours Not evaluable due to sparse sampling.	NA hours Not evaluable due to sparse sampling.	NA hours Not evaluable due to sparse sampling.	NA hours Not evaluable due to sparse sampling.	NA hours Not evaluable due to sparse sampling.	NA hours Not evaluable due to sparse sampling.	NA hours Not evaluable due to sparse sampling.	NA hours Not evaluable due to sparse sampling.	NA hours Not evaluable due to sparse sampling.	NA hours Not evaluable due to sparse sampling.	1.50 hours Interval 0.983 to 7.0	—
Time to Maximum Measured Concentration BI 836845 in Plasma (Tmax) Course 4	3.33 hours Interval 1.75 to 4.9	2.23 hours Only one evaluable subject available for this course in this dose group. Provided Median is actual value, range could not be calculated.	1.54 hours Interval 1.08 to 2.0	1.02 hours Only one evaluable subject available for this course in this dose group. Provided Median is actual value, range could not be calculated.	3.09 hours Interval 2.18 to 4.0	—	1.22 hours Only one evaluable subject available for this course in this dose group. Provided Median is actual value, range could not be calculated.	—	2.00 hours Interval 1.63 to 7.0	2.00 hours Interval 1.17 to 3.97	1.00 hours Interval 1.0 to 1.0	4.00 hours Only one evaluable subject available for this course in this dose group. Provided Median is actual value, range could not be calculated.	2.00 hours Only one evaluable subject available for this course in this dose group. Provided Median is actual value, range could not be calculated.	2.00 hours Only one evaluable subject available for this course in this dose group. Provided Median is actual value, range could not be calculated.	—	—

SECONDARY outcome

Timeframe: Up to 337 hours. Detailed timeframe is in the description.

Area under the plasma concentration-time curve from time 0 to 168 hours (AUC 0-168) of the BI 836845. As defined in the CTP, PK data is presented by BI 836845 dose level and was not collected for Course 4 part 2. For Course 1 of part 1 and part 2, Course 2 part 1 and part 2, Course 3 part 2, Course 4 part 1 the following timeframe applies : At 0.083 hour before and 0.5, 1, 2, 4, 7, 24, 72\*, 168, 169, 336 and 337 hours after infusion. \* applies only to part 1 administration courses. In Course 3 of part 1 the following timeframe applies: At 0.083 hour before and 0.5, 1, 168, 169, 336 and 337 hours after infusion. In the arm BI 836845 450 mg, data from 3 participants was available (15800, 20400 and 12700); as these 3 subjects represented less than 2/3 of the participants included in this course and this dose group, no descriptive statistics were presented in the Clinical Trial Report. The gMean and gCV values were calculated post hoc for ClinicalTrials.gov disclosure purpose only.

Outcome measures

Outcome measures
Measure	Part 1: BI 836845 n=3 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	Part 1: BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 60 mg n=3 Participants Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 90 mg n=3 Participants Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 135 mg n=3 Participants Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 200 mg n=3 Participants Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 300 mg n=3 Participants Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 450 mg n=8 Participants Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 600 mg n=3 Participants Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 800 mg n=4 Participants Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1050 mg n=3 Participants Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1400 mg n=3 Participants Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 2: Ewing's Sarcoma Family of Tumours n=13 Participants Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study	Part 2: Biopsiable Tumours Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Area Under the Plasma Concentration-time Curve of BI 836845 From Time 0 to 168 Hours (AUC 0-168) Course 1	249 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 37.2	390 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 32.9	752 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 66.3	1300 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 42.5	2250 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 16.7	3050 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 17.7	5950 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 26.9	5680 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 23.1	10600 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 12.6	15600 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 7.09	14500 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 45.6	31100 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 64.9	31800 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	36200 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	32200 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 27.4	—
Area Under the Plasma Concentration-time Curve of BI 836845 From Time 0 to 168 Hours (AUC 0-168) Course 2	265 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 49.6	627 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 41.8	1950 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	1790 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	3390 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 27.7	5150 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 52.2	9490 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 11.1	9480 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 3.39	15997 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 24.1	21400 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 13.0	22000 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 46.3	38600 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 34.0	48300 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 21.7	67600 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 9.57	55500 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 20.4	—
Area Under the Plasma Concentration-time Curve of BI 836845 From Time 0 to 168 Hours (AUC 0-168) Course 3	NA microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	NA microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Not evaluable due to sparse sampling.	53700 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 25.4	—
Area Under the Plasma Concentration-time Curve of BI 836845 From Time 0 to 168 Hours (AUC 0-168) Course 4	309 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 132	337 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	1780 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	4010 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	3620 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 3.91	—	10300 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	—	14300 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	17900 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	19000 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation 78.8	56600 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	52400 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	67400 microgram hour per milliliter (µg*h/mL) Geometric Coefficient of Variation NA Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.	—	—

SECONDARY outcome

Timeframe: First treatment administration until end of treatment plus residual effect period; Up to 74 weeks

Population: Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.

Number of patients with adverse events (AEs) according to the grading as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. The intensity of AEs was defined based on: * Grade 1 - Mild AE; awareness of sign(s) or symptom(s) which is/are easily tolerated. * Grade 2 - Moderate AE; enough discomfort to cause interference with usual activity. * Grade 3 - Severe AE; incapacitating or causing inability to work or to perform usual activities. * Grade 4 - Life-threatening or disabling AE. * Grade 5 - Death related to AE.

Outcome measures

Outcome measures
Measure	Part 1: BI 836845 n=3 Participants BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study	Part 1: BI 836845 20 mg n=3 Participants Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 40 mg n=3 Participants Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 60 mg n=3 Participants Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 90 mg n=3 Participants Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 135 mg n=3 Participants Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 200 mg n=3 Participants Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 300 mg n=3 Participants Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 450 mg n=8 Participants Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 600 mg n=3 Participants Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 800 mg n=4 Participants Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1050 mg n=3 Participants Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1400 mg n=3 Participants Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1800 mg n=3 Participants Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 2: Ewing's Sarcoma Family of Tumours n=1 Participants Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study	Part 2: Biopsiable Tumours n=12 Participants Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Incidence and Intensity of Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 1	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Incidence and Intensity of Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 2	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	4 Participants	2 Participants	2 Participants	1 Participants	0 Participants	2 Participants	1 Participants	6 Participants
Incidence and Intensity of Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	2 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants
Incidence and Intensity of Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 5	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Incidence and Intensity of Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 4	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: BI 836845 10 mg n=3 participants at risk Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 20 mg n=3 participants at risk Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 40 mg n=3 participants at risk Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 60 mg n=3 participants at risk Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 90 mg n=3 participants at risk Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 135 mg n=3 participants at risk Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 200 mg n=3 participants at risk Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 300 mg n=3 participants at risk Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 450 mg n=8 participants at risk Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 600 mg n=3 participants at risk Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 800 mg n=4 participants at risk Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1050 mg n=3 participants at risk Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1400 mg n=3 participants at risk Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1800 mg n=3 participants at risk Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 2: Ewing's Sarcoma Family of Tumours n=1 participants at risk Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study	Part 2: Biopsiable Tumours n=12 participants at risk Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Blood and lymphatic system disorders Febrile neutropenia	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
General disorders Pyrexia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Infections and infestations Device related infection	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Infections and infestations Pneumonia	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Infections and infestations Urinary tract infection	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Atrial fibrillation	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Endocrine disorders Diabetes insipidus	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Gastrointestinal mucosal disorder	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Ileus	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Infections and infestations Bacteraemia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Infections and infestations Cellulitis	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Infections and infestations Infection	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Infections and infestations Liver abscess	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Infections and infestations Peritonitis	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Infections and infestations Septic shock	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Investigations Weight decreased	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Cauda equina syndrome	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Cerebral ischaemia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Syncope	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Vascular disorders Superior vena cava syndrome	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
General disorders Pain	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.

Other adverse events

Other adverse events
Measure	Part 1: BI 836845 10 mg n=3 participants at risk Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 20 mg n=3 participants at risk Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 40 mg n=3 participants at risk Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 60 mg n=3 participants at risk Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 90 mg n=3 participants at risk Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 135 mg n=3 participants at risk Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 200 mg n=3 participants at risk Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 300 mg n=3 participants at risk Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 450 mg n=8 participants at risk Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 600 mg n=3 participants at risk Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 800 mg n=4 participants at risk Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1050 mg n=3 participants at risk Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1400 mg n=3 participants at risk Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 1: BI 836845 1800 mg n=3 participants at risk Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study	Part 2: Ewing's Sarcoma Family of Tumours n=1 participants at risk Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study	Part 2: Biopsiable Tumours n=12 participants at risk Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	66.7% 2/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	100.0% 1/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	16.7% 2/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Gastritis	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	66.7% 2/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	50.0% 2/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Abdominal distension	100.0% 3/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	66.7% 2/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	16.7% 2/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	16.7% 2/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Constipation	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	66.7% 2/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	100.0% 1/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 4/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Nausea	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 3/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Vomiting	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	100.0% 1/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 4/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
General disorders Chest discomfort	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
General disorders Chest pain	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 2/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
General disorders Fatigue	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
General disorders Malaise	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
General disorders Pyrexia	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	100.0% 1/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Hepatobiliary disorders Hyperbilirubinaemia	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Infections and infestations Catheter site infection	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Infections and infestations Oral candidiasis	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	16.7% 2/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Infections and infestations Urinary tract infection	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Investigations Alanine aminotransferase increased	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Investigations Weight decreased	100.0% 3/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	66.7% 2/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 3/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Decreased appetite	66.7% 2/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	16.7% 2/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	16.7% 2/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Dizziness	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Headache	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	66.7% 2/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Neuralgia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Tremor	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Psychiatric disorders Anxiety	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Psychiatric disorders Insomnia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	100.0% 1/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Haematuria	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Nocturia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	50.0% 4/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 2/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Vascular disorders Hypertension	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Vascular disorders Hypotension	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Atrial flutter	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Eye disorders Eye pruritus	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Eye disorders Miosis	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Eye disorders Neurotrophic keratopathy	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Ascites	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Cheilitis	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Chronic gastritis	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Epigastric discomfort	66.7% 2/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Gastric ulcer	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Inguinal hernia	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Melaena	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Oral pain	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Peptic ulcer	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Tongue ulceration	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
General disorders Asthenia	66.7% 2/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
General disorders Local swelling	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
General disorders Mucosal inflammation	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
General disorders Non-cardiac chest pain	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
General disorders Oedema	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
General disorders Oedema peripheral	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 3/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
General disorders Pain	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Hepatobiliary disorders Hepatomegaly	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Infections and infestations Conjunctivitis	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Infections and infestations Epididymitis	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Infections and infestations Pulpitis dental	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Procedural vomiting	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Wound	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Investigations Blood bilirubin increased	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Investigations Blood cholesterol increased	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 2/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Investigations Blood creatinine increased	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Investigations Lymphocyte count decreased	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Investigations Neutrophil count decreased	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Investigations Platelet count decreased	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	66.7% 2/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Investigations Pulmonary physical examination abnormal	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Investigations White blood cell count decreased	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Cachexia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 2/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	100.0% 1/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Chondritis	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Myofascial pain syndrome	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm of orbit	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Facial paresis	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Hypoaesthesia	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Paraesthesia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 2/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Psychiatric disorders Delirium	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Dysuria	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Neurogenic bladder	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Proteinuria	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Urinary retention	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Reproductive system and breast disorders Oligomenorrhoea	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	16.7% 2/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Choking	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 2/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	25.0% 1/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Sputum increased	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	12.5% 1/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	8.3% 1/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Vascular disorders Flushing	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Vascular disorders Lymphoedema	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	33.3% 1/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/8 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/4 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/3 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/1 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.	0.00% 0/12 • First treatment administration until end of treatment plus residual effect period; Up to 74 weeks. Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER