Trial Outcomes & Findings for Evaluation of Safety and Tolerability of BI 894416 in Patients With Mild Asthma (NCT NCT03971539)

NCT ID: NCT03971539

Last Updated: 2023-08-21

Results Overview

Percentage of patients with treatment-emergent adverse events (AEs) related to BI 894416.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

68 participants

Primary outcome timeframe

From start of treatment till the end of trial, up to 30 days.

Results posted on

2023-08-21

Participant Flow

The trial was randomised, placebo-controlled within groups, and single blinded. The trial consisted of a single rising dose (SRD) and a multiple rising dose (MRD) part. Last follow-up visit occurred between 14 and 16 days after the single dose for the SRD part and between day 14 and 21 days after the last dose for the MRD part.

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

Participant milestones

Participant milestones
Measure	SRD Part: Placebo Single rising dose (SRD) part: Placebo film-coated tablet matching BI 894416 taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 75 mg BI 894416 Single rising dose (SRD) part: 75 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 125 mg BI 894416 Single rising dose (SRD) part: 125 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 170 mg BI 894416 Single rising dose (SRD) part: 170 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	MRD Part: Placebo Multiple rising dose (MRD) part: Placebo film-coated tablet matching BI 894416 taken for 9 days orally with 240 milliliter of water. Administration of Placebo at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 10 mg BI 894416 Multiple rising dose (MRD) part: 10 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 25 mg BI 894416 Multiple rising dose (MRD) part: 25 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 50 mg BI 894416 Multiple rising dose (MRD) part: 50 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 60 mg BI 894416 Multiple rising dose (MRD) part: 60 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.
Overall Study STARTED	6	7	8	8	8	7	8	8	8
Overall Study COMPLETED	6	7	8	8	8	7	8	8	8
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Safety and Tolerability of BI 894416 in Patients With Mild Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SRD Part: Placebo n=6 Participants Single rising dose (SRD) part: Placebo film-coated tablet matching BI 894416 taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 75 mg BI 894416 n=7 Participants Single rising dose (SRD) part: 75 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 125 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 125 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 170 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 170 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	MRD Part: Placebo n=8 Participants Multiple rising dose (MRD) part: Placebo film-coated tablet matching BI 894416 taken for 9 days orally with 240 milliliter of water. Administration of Placebo at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 10 mg BI 894416 n=7 Participants Multiple rising dose (MRD) part: 10 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 25 mg BI 894416 n=8 Participants Multiple rising dose (MRD) part: 25 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 50 mg BI 894416 n=8 Participants Multiple rising dose (MRD) part: 50 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 60 mg BI 894416 n=8 Participants Multiple rising dose (MRD) part: 60 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	Total n=68 Participants Total of all reporting groups
Age, Continuous	38.7 years STANDARD_DEVIATION 12.3 • n=5 Participants	30.6 years STANDARD_DEVIATION 7.2 • n=7 Participants	27.1 years STANDARD_DEVIATION 7.5 • n=5 Participants	29.3 years STANDARD_DEVIATION 9.3 • n=4 Participants	26.1 years STANDARD_DEVIATION 4.4 • n=21 Participants	32.7 years STANDARD_DEVIATION 11.2 • n=8 Participants	29.9 years STANDARD_DEVIATION 10.6 • n=8 Participants	30.9 years STANDARD_DEVIATION 9.0 • n=24 Participants	28.9 years STANDARD_DEVIATION 9.0 • n=42 Participants	30.2 years STANDARD_DEVIATION 9.1 • n=42 Participants
Sex: Female, Male Female	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
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	7 Participants n=8 Participants	8 Participants n=8 Participants	8 Participants n=24 Participants	8 Participants n=42 Participants	68 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	8 Participants n=21 Participants	7 Participants n=8 Participants	7 Participants n=8 Participants	8 Participants n=24 Participants	8 Participants n=42 Participants	66 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	1 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	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 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
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	1 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	7 Participants n=8 Participants	7 Participants n=8 Participants	8 Participants n=24 Participants	7 Participants n=42 Participants	65 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	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
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

PRIMARY outcome

Timeframe: From start of treatment till the end of trial, up to 30 days.

Population: Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.

Percentage of patients with treatment-emergent adverse events (AEs) related to BI 894416.

Outcome measures

Outcome measures
Measure	SRD Part: Placebo n=6 Participants Single rising dose (SRD) part: Placebo film-coated tablet matching BI 894416 taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 75 mg BI 894416 n=7 Participants Single rising dose (SRD) part: 75 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 125 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 125 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 170 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 170 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	MRD Part: Placebo n=8 Participants Multiple rising dose (MRD) part: Placebo film-coated tablet matching BI 894416 taken for 9 days orally with 240 milliliter of water. Administration of Placebo at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 10 mg BI 894416 n=7 Participants Multiple rising dose (MRD) part: 10 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 25 mg BI 894416 n=8 Participants Multiple rising dose (MRD) part: 25 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 50 mg BI 894416 n=8 Participants Multiple rising dose (MRD) part: 50 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 60 mg BI 894416 n=8 Participants Multiple rising dose (MRD) part: 60 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	SRD Part: Total BI 894416 n=23 Participants Single rising dose (SRD) part, total of all subjects treated with BI 894416 (75 mg, 125 mg and 170 mg).	SRD Part: Total (BI 894416 and Placebo) n=29 Participants Single rising dose (SRD) part, total of all subjects in SRD part (75 mg, 125 mg 170 mg and placebo).	MRD Part: Total BI 894416 n=31 Participants Multiple rising dose (MRD) part, total of all subjects treated with BI 894416 (10 mg, 25 mg, 50 mg and 60 mg).	MRD Part: Total (BI 894416 and Placebo) n=39 Participants Multiple rising dose (MRD) part, total of all subjects in MRD part (10 mg, 25 mg, 50 mg, 60 mg and placebo).
Percentage of Patients With Treatment-emergent Adverse Events Related to BI 894416	0 Percentage of participants	28.6 Percentage of participants	37.5 Percentage of participants	62.5 Percentage of participants	0.0 Percentage of participants	28.6 Percentage of participants	0.0 Percentage of participants	25.0 Percentage of participants	25.0 Percentage of participants	43.5 Percentage of participants	34.5 Percentage of participants	19.4 Percentage of participants	15.4 Percentage of participants

SECONDARY outcome

Timeframe: 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72 and 96 hours following treatment.

Population: Pharmacokinetic set (PKS): the PKS includes all patients in the TS who provided at least one pharmacokinetic endpoint that was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics, or due to pharmacokinetic non-evaluability.

AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of BI 894416 (single rising dose part).

Outcome measures

Outcome measures
Measure	SRD Part: Placebo n=7 Participants Single rising dose (SRD) part: Placebo film-coated tablet matching BI 894416 taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 75 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 75 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 125 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 125 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 170 mg BI 894416 Single rising dose (SRD) part: 170 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	MRD Part: Placebo Multiple rising dose (MRD) part: Placebo film-coated tablet matching BI 894416 taken for 9 days orally with 240 milliliter of water. Administration of Placebo at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 10 mg BI 894416 Multiple rising dose (MRD) part: 10 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 25 mg BI 894416 Multiple rising dose (MRD) part: 25 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 50 mg BI 894416 Multiple rising dose (MRD) part: 50 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 60 mg BI 894416 Multiple rising dose (MRD) part: 60 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	SRD Part: Total BI 894416 Single rising dose (SRD) part, total of all subjects treated with BI 894416 (75 mg, 125 mg and 170 mg).	SRD Part: Total (BI 894416 and Placebo) Single rising dose (SRD) part, total of all subjects in SRD part (75 mg, 125 mg 170 mg and placebo).	MRD Part: Total BI 894416 Multiple rising dose (MRD) part, total of all subjects treated with BI 894416 (10 mg, 25 mg, 50 mg and 60 mg).	MRD Part: Total (BI 894416 and Placebo) Multiple rising dose (MRD) part, total of all subjects in MRD part (10 mg, 25 mg, 50 mg, 60 mg and placebo).
AUC0-∞ (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) of BI 894416 (SRD Part)	15900 Nanomoles*hours/liter Geometric Coefficient of Variation 41.5	26400 Nanomoles*hours/liter Geometric Coefficient of Variation 30.0	32500 Nanomoles*hours/liter Geometric Coefficient of Variation 21.9	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72 and 96 hours following treatment.

Cmax (maximum measured concentration of the analyte in plasma) of BI 894416 (single rising dose part).

Outcome measures

Outcome measures
Measure	SRD Part: Placebo n=7 Participants Single rising dose (SRD) part: Placebo film-coated tablet matching BI 894416 taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 75 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 75 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 125 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 125 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 170 mg BI 894416 Single rising dose (SRD) part: 170 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	MRD Part: Placebo Multiple rising dose (MRD) part: Placebo film-coated tablet matching BI 894416 taken for 9 days orally with 240 milliliter of water. Administration of Placebo at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 10 mg BI 894416 Multiple rising dose (MRD) part: 10 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 25 mg BI 894416 Multiple rising dose (MRD) part: 25 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 50 mg BI 894416 Multiple rising dose (MRD) part: 50 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 60 mg BI 894416 Multiple rising dose (MRD) part: 60 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	SRD Part: Total BI 894416 Single rising dose (SRD) part, total of all subjects treated with BI 894416 (75 mg, 125 mg and 170 mg).	SRD Part: Total (BI 894416 and Placebo) Single rising dose (SRD) part, total of all subjects in SRD part (75 mg, 125 mg 170 mg and placebo).	MRD Part: Total BI 894416 Multiple rising dose (MRD) part, total of all subjects treated with BI 894416 (10 mg, 25 mg, 50 mg and 60 mg).	MRD Part: Total (BI 894416 and Placebo) Multiple rising dose (MRD) part, total of all subjects in MRD part (10 mg, 25 mg, 50 mg, 60 mg and placebo).
Cmax (Maximum Measured Concentration of the Analyte in Plasma) of BI 894416 (SRD Part)	2340 Nanomoles/liter Geometric Coefficient of Variation 29.7	4240 Nanomoles/liter Geometric Coefficient of Variation 25.3	5280 Nanomoles/liter Geometric Coefficient of Variation 24.3	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 5 minutes before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 hours following first dose (day 1).

AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 8 hours) of BI 894416 after the first dose (Multiple rising dose part).

Outcome measures

Outcome measures
Measure	SRD Part: Placebo n=7 Participants Single rising dose (SRD) part: Placebo film-coated tablet matching BI 894416 taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 75 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 75 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 125 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 125 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 170 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 170 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	MRD Part: Placebo Multiple rising dose (MRD) part: Placebo film-coated tablet matching BI 894416 taken for 9 days orally with 240 milliliter of water. Administration of Placebo at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 10 mg BI 894416 Multiple rising dose (MRD) part: 10 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 25 mg BI 894416 Multiple rising dose (MRD) part: 25 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 50 mg BI 894416 Multiple rising dose (MRD) part: 50 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 60 mg BI 894416 Multiple rising dose (MRD) part: 60 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	SRD Part: Total BI 894416 Single rising dose (SRD) part, total of all subjects treated with BI 894416 (75 mg, 125 mg and 170 mg).	SRD Part: Total (BI 894416 and Placebo) Single rising dose (SRD) part, total of all subjects in SRD part (75 mg, 125 mg 170 mg and placebo).	MRD Part: Total BI 894416 Multiple rising dose (MRD) part, total of all subjects treated with BI 894416 (10 mg, 25 mg, 50 mg and 60 mg).	MRD Part: Total (BI 894416 and Placebo) Multiple rising dose (MRD) part, total of all subjects in MRD part (10 mg, 25 mg, 50 mg, 60 mg and placebo).
AUC0-8 (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 8 Hours) of BI 894416 After the First Dose (MRD Part)	992 Nanomoles*hours/liter Geometric Coefficient of Variation 28.1	3130 Nanomoles*hours/liter Geometric Coefficient of Variation 9.62	4320 Nanomoles*hours/liter Geometric Coefficient of Variation 28.4	7310 Nanomoles*hours/liter Geometric Coefficient of Variation 35.1	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 5 minutes before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23.92 hours following first dose (day 1).

Cmax (maximum measured concentration of the analyte in plasma) of BI 894416 after the first dose (Multiple rising dose part).

Outcome measures

Outcome measures
Measure	SRD Part: Placebo n=7 Participants Single rising dose (SRD) part: Placebo film-coated tablet matching BI 894416 taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 75 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 75 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 125 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 125 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 170 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 170 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	MRD Part: Placebo Multiple rising dose (MRD) part: Placebo film-coated tablet matching BI 894416 taken for 9 days orally with 240 milliliter of water. Administration of Placebo at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 10 mg BI 894416 Multiple rising dose (MRD) part: 10 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 25 mg BI 894416 Multiple rising dose (MRD) part: 25 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 50 mg BI 894416 Multiple rising dose (MRD) part: 50 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 60 mg BI 894416 Multiple rising dose (MRD) part: 60 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	SRD Part: Total BI 894416 Single rising dose (SRD) part, total of all subjects treated with BI 894416 (75 mg, 125 mg and 170 mg).	SRD Part: Total (BI 894416 and Placebo) Single rising dose (SRD) part, total of all subjects in SRD part (75 mg, 125 mg 170 mg and placebo).	MRD Part: Total BI 894416 Multiple rising dose (MRD) part, total of all subjects treated with BI 894416 (10 mg, 25 mg, 50 mg and 60 mg).	MRD Part: Total (BI 894416 and Placebo) Multiple rising dose (MRD) part, total of all subjects in MRD part (10 mg, 25 mg, 50 mg, 60 mg and placebo).
Cmax (Maximum Measured Concentration of the Analyte in Plasma) of BI 894416 After the First Dose (MRD Part)	239 Nanomoles/liter Geometric Coefficient of Variation 31.6	704 Nanomoles/liter Geometric Coefficient of Variation 20.6	1170 Nanomoles/liter Geometric Coefficient of Variation 40.0	1730 Nanomoles/liter Geometric Coefficient of Variation 49.5	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 5 minutes before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours following last dose (day 9).

AUCtau,ss (area under the concentration-time curve of the analyte in plasma at steady state) of BI 894416 after the last dose (Multiple rising dose part).

Outcome measures

Outcome measures
Measure	SRD Part: Placebo n=7 Participants Single rising dose (SRD) part: Placebo film-coated tablet matching BI 894416 taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 75 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 75 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 125 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 125 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 170 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 170 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	MRD Part: Placebo Multiple rising dose (MRD) part: Placebo film-coated tablet matching BI 894416 taken for 9 days orally with 240 milliliter of water. Administration of Placebo at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 10 mg BI 894416 Multiple rising dose (MRD) part: 10 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 25 mg BI 894416 Multiple rising dose (MRD) part: 25 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 50 mg BI 894416 Multiple rising dose (MRD) part: 50 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 60 mg BI 894416 Multiple rising dose (MRD) part: 60 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	SRD Part: Total BI 894416 Single rising dose (SRD) part, total of all subjects treated with BI 894416 (75 mg, 125 mg and 170 mg).	SRD Part: Total (BI 894416 and Placebo) Single rising dose (SRD) part, total of all subjects in SRD part (75 mg, 125 mg 170 mg and placebo).	MRD Part: Total BI 894416 Multiple rising dose (MRD) part, total of all subjects treated with BI 894416 (10 mg, 25 mg, 50 mg and 60 mg).	MRD Part: Total (BI 894416 and Placebo) Multiple rising dose (MRD) part, total of all subjects in MRD part (10 mg, 25 mg, 50 mg, 60 mg and placebo).
AUCtau,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State) of BI 894416 After the Last Dose (MRD Part)	1460 Nanomoles*hours/liter Geometric Coefficient of Variation 48.6	4770 Nanomoles*hours/liter Geometric Coefficient of Variation 19.7	5420 Nanomoles*hours/liter Geometric Coefficient of Variation 33.2	9400 Nanomoles*hours/liter Geometric Coefficient of Variation 30.6	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 5 minutes before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours following last dose (day 9).

Cmax,ss (maximum measured concentration of the analyte in plasma at steady state) of BI 894416 after the last dose (Multiple rising dose part).

Outcome measures

Outcome measures
Measure	SRD Part: Placebo n=7 Participants Single rising dose (SRD) part: Placebo film-coated tablet matching BI 894416 taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 75 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 75 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 125 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 125 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 170 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 170 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	MRD Part: Placebo Multiple rising dose (MRD) part: Placebo film-coated tablet matching BI 894416 taken for 9 days orally with 240 milliliter of water. Administration of Placebo at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 10 mg BI 894416 Multiple rising dose (MRD) part: 10 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 25 mg BI 894416 Multiple rising dose (MRD) part: 25 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 50 mg BI 894416 Multiple rising dose (MRD) part: 50 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 60 mg BI 894416 Multiple rising dose (MRD) part: 60 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	SRD Part: Total BI 894416 Single rising dose (SRD) part, total of all subjects treated with BI 894416 (75 mg, 125 mg and 170 mg).	SRD Part: Total (BI 894416 and Placebo) Single rising dose (SRD) part, total of all subjects in SRD part (75 mg, 125 mg 170 mg and placebo).	MRD Part: Total BI 894416 Multiple rising dose (MRD) part, total of all subjects treated with BI 894416 (10 mg, 25 mg, 50 mg and 60 mg).	MRD Part: Total (BI 894416 and Placebo) Multiple rising dose (MRD) part, total of all subjects in MRD part (10 mg, 25 mg, 50 mg, 60 mg and placebo).
Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State) of BI 894416 After the Last Dose (MRD Part)	299 Nanomoles/liter Geometric Coefficient of Variation 42.7	985 Nanomoles/liter Geometric Coefficient of Variation 19.4	1290 Nanomoles/liter Geometric Coefficient of Variation 52.1	2130 Nanomoles/liter Geometric Coefficient of Variation 30.3	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 9 days.

Difference in airway resistance (RAW) from baseline (measured on day 1) to day 9, after 7 days (day 2-8) of t.i.d. (three times daily) treatment.

Outcome measures

Outcome measures
Measure	SRD Part: Placebo n=8 Participants Single rising dose (SRD) part: Placebo film-coated tablet matching BI 894416 taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 75 mg BI 894416 n=7 Participants Single rising dose (SRD) part: 75 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 125 mg BI 894416 n=8 Participants Single rising dose (SRD) part: 125 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 170 mg BI 894416 n=7 Participants Single rising dose (SRD) part: 170 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	MRD Part: Placebo n=8 Participants Multiple rising dose (MRD) part: Placebo film-coated tablet matching BI 894416 taken for 9 days orally with 240 milliliter of water. Administration of Placebo at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 10 mg BI 894416 Multiple rising dose (MRD) part: 10 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 25 mg BI 894416 Multiple rising dose (MRD) part: 25 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 50 mg BI 894416 Multiple rising dose (MRD) part: 50 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 60 mg BI 894416 Multiple rising dose (MRD) part: 60 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	SRD Part: Total BI 894416 Single rising dose (SRD) part, total of all subjects treated with BI 894416 (75 mg, 125 mg and 170 mg).	SRD Part: Total (BI 894416 and Placebo) Single rising dose (SRD) part, total of all subjects in SRD part (75 mg, 125 mg 170 mg and placebo).	MRD Part: Total BI 894416 Multiple rising dose (MRD) part, total of all subjects treated with BI 894416 (10 mg, 25 mg, 50 mg and 60 mg).	MRD Part: Total (BI 894416 and Placebo) Multiple rising dose (MRD) part, total of all subjects in MRD part (10 mg, 25 mg, 50 mg, 60 mg and placebo).
Difference From Baseline in Airway Resistance (RAW) After 7 Days of Treatment (MRD Part)	0.052 kilopascal/liter/second Standard Deviation 0.086	0.069 kilopascal/liter/second Standard Deviation 0.026	0.041 kilopascal/liter/second Standard Deviation 0.038	0.041 kilopascal/liter/second Standard Deviation 0.066	0.000 kilopascal/liter/second Standard Deviation 0.082	—	—	—	—	—	—	—	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SRD Part: Placebo n=6 participants at risk Single rising dose (SRD) part: Placebo film-coated tablet matching BI 894416 taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 75 mg BI 894416 n=7 participants at risk Single rising dose (SRD) part: 75 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 125 mg BI 894416 n=8 participants at risk Single rising dose (SRD) part: 125 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	SRD Part: 170 mg BI 894416 n=8 participants at risk Single rising dose (SRD) part: 170 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.	MRD Part: Placebo n=8 participants at risk Multiple rising dose (MRD) part: Placebo film-coated tablet matching BI 894416 taken for 9 days orally with 240 milliliter of water. Administration of Placebo at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 10 mg BI 894416 n=7 participants at risk Multiple rising dose (MRD) part: 10 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 25 mg BI 894416 n=8 participants at risk Multiple rising dose (MRD) part: 25 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 50 mg BI 894416 n=8 participants at risk Multiple rising dose (MRD) part: 50 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	MRD Part: 60 mg BI 894416 n=8 participants at risk Multiple rising dose (MRD) part: 60 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours.	SRD Part: Total BI 894416 n=23 participants at risk Single rising dose (SRD) part, total of all subjects treated with BI 894416 (75 mg, 125 mg and 170 mg).	SRD Part: Total (BI 894416 and Placebo) n=29 participants at risk Single rising dose (SRD) part, total of all subjects in SRD part (75 mg, 125 mg 170 mg and placebo).	MRD Part: Total BI 894416 n=31 participants at risk Multiple rising dose (MRD) part, total of all subjects treated with BI 894416 (10 mg, 25 mg, 50 mg and 60 mg).	MRD Part: Total (BI 894416 and Placebo) n=39 participants at risk Multiple rising dose (MRD) part, total of all subjects in MRD part (10 mg, 25 mg, 50 mg, 60 mg and placebo).	Total BI 894416 n=54 participants at risk All subjects treated with BI 894416 in either the single rising dose or multiple rising dose part.	Total n=68 participants at risk All subjects in the study.
Renal and urinary disorders Micturition urgency	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Renal and urinary disorders Haematuria	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	4.3% 1/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	6.5% 2/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	5.1% 2/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.7% 2/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.9% 2/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	14.3% 1/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Blood and lymphatic system disorders Neutropenia	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	14.3% 1/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	4.3% 1/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Cardiac disorders Palpitations	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	14.3% 1/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Eye disorders Conjunctival haemorrhage	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	14.3% 1/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	4.3% 1/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.7% 2/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.9% 2/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Gastrointestinal disorders Faeces soft	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	14.3% 1/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	5.1% 2/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.9% 2/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Gastrointestinal disorders Flatulence	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	37.5% 3/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	9.7% 3/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	10.3% 4/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	5.6% 3/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	5.9% 4/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Gastrointestinal disorders Nausea	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	25.0% 2/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	14.3% 1/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	8.7% 2/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	6.9% 2/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	5.6% 3/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	4.4% 3/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
General disorders Chest discomfort	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	14.3% 1/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	4.3% 1/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
General disorders Fatigue	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
General disorders Medical device site pruritus	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
General disorders Sluggishness	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Immune system disorders Mite allergy	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	4.3% 1/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Infections and infestations Eyelid infection	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Infections and infestations Lower respiratory tract infection	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	14.3% 1/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	8.7% 2/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	6.9% 2/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	6.5% 2/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	5.1% 2/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	7.4% 4/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	5.9% 4/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Infections and infestations Nasopharyngitis	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	4.3% 1/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.7% 2/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.9% 2/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Infections and infestations Otitis externa	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	4.3% 1/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	4.3% 1/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	14.3% 1/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	14.3% 1/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	4.3% 1/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.7% 2/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.9% 2/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	4.3% 1/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Injury, poisoning and procedural complications Skin injury	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	4.3% 1/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Investigations Alanine aminotransferase increased	16.7% 1/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Investigations Aspartate aminotransferase increased	16.7% 1/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Investigations Blood creatine phosphokinase increased	16.7% 1/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Investigations Blood pressure increased	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	25.0% 2/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	4.3% 1/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	9.7% 3/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	7.7% 3/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	7.4% 4/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	5.9% 4/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Nervous system disorders Head discomfort	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Nervous system disorders Headache	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	28.6% 2/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	50.0% 4/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	87.5% 7/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	37.5% 3/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	14.3% 1/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	37.5% 3/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	37.5% 3/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	56.5% 13/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	44.8% 13/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	22.6% 7/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	25.6% 10/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	37.0% 20/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	33.8% 23/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Nervous system disorders Nerve compression	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	6.5% 2/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	5.1% 2/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.7% 2/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.9% 2/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Nervous system disorders Presyncope	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	5.1% 2/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.9% 2/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Nervous system disorders Tension headache	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	14.3% 1/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	4.3% 1/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Psychiatric disorders Anxiety disorder	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Psychiatric disorders Insomnia	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Renal and urinary disorders Bladder pain	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	14.3% 1/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	4.3% 1/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	25.0% 2/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	6.5% 2/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	5.1% 2/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.7% 2/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.9% 2/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.2% 1/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	2.6% 1/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/6 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	12.5% 1/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/7 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/8 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	4.3% 1/23 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	3.4% 1/29 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/31 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	0.00% 0/39 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.9% 1/54 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.	1.5% 1/68 • From start of treatment till the end of trial, up to 30 days. Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.

Additional Information

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