Trial Outcomes & Findings for A Study to Test How Well Healthy Men Tolerate Different Doses of BI 706321 (NCT NCT03971695)

NCT ID: NCT03971695

Last Updated: 2025-09-18

Results Overview

Part I: Percentage of subjects with drug-related adverse events.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

73 participants

Primary outcome timeframe

Between intake of trial medication and the individual subject's end of trial, up to 22 days.

Results posted on

2025-09-18

Participant Flow

Part I of the trial was designed as randomised, placebo-controlled, and single-blind, within parallel dose groups. Part II of the trial was designed as a randomised, open-label, 3-way crossover to compare the treatments T1 and R (comparison A) and T2 and T1 (comparison B).

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

Participant milestones

Participant milestones
Measure	Part I - Placebo Oral Solution Part I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 0.3 mg BI 706321 Oral Solution Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 0.6 mg BI 706321 Oral Solution Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 1.2 mg BI 706321 Oral Solution Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - Placebo Capsules Part I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 2 mg BI 706321 Capsules Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 4 mg BI 706321 Capsules Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 8 mg BI 706321 Capsules Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 15 mg BI 706321 Capsules Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 25 mg BI 706321 Capsules Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part II - R-T1-T2 Part II - R-T1-T2 - Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast. Treatments in Part II were separated by a washout period of at least 12 days.	Part II - T1-T2-R Part II - T1-T2-R - Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast. Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Treatments in Part II were separated by a washout period of at least 12 days.	Part II - T2-R-T1 Part II - T2-R-T1 - Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast. Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Treatments in Part II were separated by a washout period of at least 12 days.
Part I and Period 1 of Part II STARTED	6	6	6	5	9	6	6	6	5	6	4	4	4
Part I and Period 1 of Part II COMPLETED	6	6	6	5	9	6	6	6	5	6	4	4	4
Part I and Period 1 of Part II NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
End of Part I and Part II - Washout STARTED	6	6	6	5	9	6	6	6	5	6	4	4	4
End of Part I and Part II - Washout COMPLETED	0	0	0	0	0	0	0	0	0	0	4	4	4
End of Part I and Part II - Washout NOT COMPLETED	6	6	6	5	9	6	6	6	5	6	0	0	0
Part II - Period 2 STARTED	0	0	0	0	0	0	0	0	0	0	4	4	4
Part II - Period 2 COMPLETED	0	0	0	0	0	0	0	0	0	0	4	4	4
Part II - Period 2 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Part II - Washout (of at Least 12 Days) STARTED	0	0	0	0	0	0	0	0	0	0	4	4	4
Part II - Washout (of at Least 12 Days) COMPLETED	0	0	0	0	0	0	0	0	0	0	4	4	4
Part II - Washout (of at Least 12 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0
Part II - Period 3 STARTED	0	0	0	0	0	0	0	0	0	0	4	4	4
Part II - Period 3 COMPLETED	0	0	0	0	0	0	0	0	0	0	4	4	4
Part II - Period 3 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part I - Placebo Oral Solution Part I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 0.3 mg BI 706321 Oral Solution Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 0.6 mg BI 706321 Oral Solution Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 1.2 mg BI 706321 Oral Solution Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - Placebo Capsules Part I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 2 mg BI 706321 Capsules Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 4 mg BI 706321 Capsules Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 8 mg BI 706321 Capsules Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 15 mg BI 706321 Capsules Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 25 mg BI 706321 Capsules Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part II - R-T1-T2 Part II - R-T1-T2 - Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast. Treatments in Part II were separated by a washout period of at least 12 days.	Part II - T1-T2-R Part II - T1-T2-R - Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast. Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Treatments in Part II were separated by a washout period of at least 12 days.	Part II - T2-R-T1 Part II - T2-R-T1 - Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast. Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Treatments in Part II were separated by a washout period of at least 12 days.
End of Part I and Part II - Washout Did not participate in part II of study	6	6	6	5	9	6	6	6	5	6	0	0	0

Baseline Characteristics

A Study to Test How Well Healthy Men Tolerate Different Doses of BI 706321

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part I - Placebo Oral Solution n=6 Participants Part I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 0.3 mg BI 706321 Oral Solution n=6 Participants Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 0.6 mg BI 706321 Oral Solution n=6 Participants Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 1.2 mg BI 706321 Oral Solution n=5 Participants Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - Placebo Capsules n=9 Participants Part I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 2 mg BI 706321 Capsules n=6 Participants Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 4 mg BI 706321 Capsules n=6 Participants Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 8 mg BI 706321 Capsules n=6 Participants Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 15 mg BI 706321 Capsules n=5 Participants Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 25 mg BI 706321 Capsules n=6 Participants Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part II - R-T1-T2 n=4 Participants Part II - R-T1-T2 - Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast. Treatments in Part II were separated by a washout period of at least 12 days.	Part II - T1-T2-R n=4 Participants Part II - T1-T2-R - Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast. Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Treatments in Part II were separated by a washout period of at least 12 days.	Part II - T2-R-T1 n=4 Participants Part II - T2-R-T1 - Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast. Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Treatments in Part II were separated by a washout period of at least 12 days.	Total n=73 Participants Total of all reporting groups
Age, Continuous	32.8 years STANDARD_DEVIATION 4.7 • n=5 Participants	28.8 years STANDARD_DEVIATION 4.8 • n=7 Participants	30.3 years STANDARD_DEVIATION 3.9 • n=5 Participants	32.8 years STANDARD_DEVIATION 4.4 • n=4 Participants	32.3 years STANDARD_DEVIATION 5.9 • n=21 Participants	29.2 years STANDARD_DEVIATION 4.9 • n=8 Participants	35.3 years STANDARD_DEVIATION 6.8 • n=8 Participants	30.2 years STANDARD_DEVIATION 6.2 • n=24 Participants	29.6 years STANDARD_DEVIATION 2.9 • n=42 Participants	32.2 years STANDARD_DEVIATION 7.8 • n=42 Participants	39.8 years STANDARD_DEVIATION 6.4 • n=42 Participants	42.0 years STANDARD_DEVIATION 11.5 • n=42 Participants	35.0 years STANDARD_DEVIATION 12.5 • n=36 Participants	32.6 years STANDARD_DEVIATION 6.9 • n=36 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	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	9 Participants n=21 Participants	6 Participants n=8 Participants	6 Participants n=8 Participants	6 Participants n=24 Participants	5 Participants n=42 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=36 Participants	73 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	9 Participants n=21 Participants	6 Participants n=8 Participants	6 Participants n=8 Participants	6 Participants n=24 Participants	5 Participants n=42 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=36 Participants	73 Participants n=36 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	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	9 Participants n=21 Participants	6 Participants n=8 Participants	6 Participants n=8 Participants	6 Participants n=24 Participants	5 Participants n=42 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=36 Participants	73 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants

PRIMARY outcome

Timeframe: Between intake of trial medication and the individual subject's end of trial, up to 22 days.

Population: Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.

Part I: Percentage of subjects with drug-related adverse events.

Outcome measures

Outcome measures
Measure	Part I - Placebo Oral Solution n=6 Participants Part I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 0.3 mg BI 706321 Oral Solution n=6 Participants Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 0.6 mg BI 706321 Oral Solution n=6 Participants Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 1.2 mg BI 706321 Oral Solution n=5 Participants Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - Placebo Capsules n=9 Participants Part I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 2 mg BI 706321 Capsules n=6 Participants Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 4 mg BI 706321 Capsules n=6 Participants Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 8 mg BI 706321 Capsules n=6 Participants Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 15 mg BI 706321 Capsules n=5 Participants Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 25 mg BI 706321 Capsules n=6 Participants Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.
Part I: Percentage of Subjects With Drug-related Adverse Events	16.7 Percentage of participants	16.7 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	11.1 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	16.7 Percentage of participants	20.0 Percentage of participants	33.3 Percentage of participants

PRIMARY outcome

Timeframe: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 168 hours after drug administration.

Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK.

Part II: Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).

Outcome measures

Outcome measures
Measure	Part I - Placebo Oral Solution n=12 Participants Part I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 0.3 mg BI 706321 Oral Solution n=12 Participants Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 0.6 mg BI 706321 Oral Solution n=12 Participants Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 1.2 mg BI 706321 Oral Solution Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - Placebo Capsules Part I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 2 mg BI 706321 Capsules Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 4 mg BI 706321 Capsules Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 8 mg BI 706321 Capsules Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 15 mg BI 706321 Capsules Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 25 mg BI 706321 Capsules Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.
Part II: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	150 hour*nanomol/liter Geometric Coefficient of Variation 27.5	138 hour*nanomol/liter Geometric Coefficient of Variation 29.9	150 hour*nanomol/liter Geometric Coefficient of Variation 29.5	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 168 hours after drug administration.

Part II: Maximum measured concentration of BI 706321 in plasma (Cmax).

Outcome measures

Outcome measures
Measure	Part I - Placebo Oral Solution n=12 Participants Part I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 0.3 mg BI 706321 Oral Solution n=12 Participants Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 0.6 mg BI 706321 Oral Solution n=12 Participants Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 1.2 mg BI 706321 Oral Solution Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - Placebo Capsules Part I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 2 mg BI 706321 Capsules Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 4 mg BI 706321 Capsules Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 8 mg BI 706321 Capsules Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 15 mg BI 706321 Capsules Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 25 mg BI 706321 Capsules Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.
Part II: Maximum Measured Concentration of BI 706321 in Plasma (Cmax)	5.90 nanomol/liter Geometric Coefficient of Variation 47.8	4.57 nanomol/liter Geometric Coefficient of Variation 33.6	6.02 nanomol/liter Geometric Coefficient of Variation 41.1	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 168 hours after drug administration.

Part I: Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

Outcome measures

Outcome measures
Measure	Part I - Placebo Oral Solution n=6 Participants Part I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 0.3 mg BI 706321 Oral Solution n=6 Participants Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 0.6 mg BI 706321 Oral Solution n=5 Participants Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 1.2 mg BI 706321 Oral Solution n=6 Participants Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - Placebo Capsules n=5 Participants Part I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 2 mg BI 706321 Capsules n=6 Participants Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 4 mg BI 706321 Capsules n=5 Participants Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 8 mg BI 706321 Capsules n=6 Participants Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 15 mg BI 706321 Capsules Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 25 mg BI 706321 Capsules Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.
Part I: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	NA hour*nanomol/liter Geometric Coefficient of Variation NA Not calculated due to insufficient concentration data above the lower limit of assay quantitation	NA hour*nanomol/liter Geometric Coefficient of Variation NA Not calculated due to insufficient concentration data above the lower limit of assay quantitation	NA hour*nanomol/liter Geometric Coefficient of Variation NA Not calculated due to insufficient concentration data above the lower limit of assay quantitation	NA hour*nanomol/liter Geometric Coefficient of Variation NA Not calculated due to insufficient concentration data above the lower limit of assay quantitation	151 hour*nanomol/liter Geometric Coefficient of Variation 33.1	314 hour*nanomol/liter Geometric Coefficient of Variation 25.7	618 hour*nanomol/liter Geometric Coefficient of Variation 36.1	1130 hour*nanomol/liter Geometric Coefficient of Variation 24.2	—	—

SECONDARY outcome

Timeframe: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 168 hours after drug administration.

Part I: Maximum measured concentration of BI 706321 in plasma (Cmax).

Outcome measures

Outcome measures
Measure	Part I - Placebo Oral Solution n=6 Participants Part I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 0.3 mg BI 706321 Oral Solution n=6 Participants Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 0.6 mg BI 706321 Oral Solution n=5 Participants Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 1.2 mg BI 706321 Oral Solution n=6 Participants Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - Placebo Capsules n=5 Participants Part I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 2 mg BI 706321 Capsules n=6 Participants Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 4 mg BI 706321 Capsules n=5 Participants Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 8 mg BI 706321 Capsules n=6 Participants Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 15 mg BI 706321 Capsules Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 25 mg BI 706321 Capsules Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.
Part I: Maximum Measured Concentration of BI 706321 in Plasma (Cmax)	0.388 nanomol/liter Geometric Coefficient of Variation 32.8	0.781 nanomol/liter Geometric Coefficient of Variation 21.4	1.02 nanomol/liter Geometric Coefficient of Variation 40.0	2.27 nanomol/liter Geometric Coefficient of Variation 30.1	5.19 nanomol/liter Geometric Coefficient of Variation 38.6	11.8 nanomol/liter Geometric Coefficient of Variation 41.6	24.6 nanomol/liter Geometric Coefficient of Variation 43.0	41.1 nanomol/liter Geometric Coefficient of Variation 32.1	—	—

SECONDARY outcome

Timeframe: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 168 hours after drug administration.

Part I: Time from dosing to the maximum measured concentration of BI 706321 in plasma (tmax).

Outcome measures

Outcome measures
Measure	Part I - Placebo Oral Solution n=6 Participants Part I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 0.3 mg BI 706321 Oral Solution n=6 Participants Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 0.6 mg BI 706321 Oral Solution n=5 Participants Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 1.2 mg BI 706321 Oral Solution n=6 Participants Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - Placebo Capsules n=5 Participants Part I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 2 mg BI 706321 Capsules n=6 Participants Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 4 mg BI 706321 Capsules n=5 Participants Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 8 mg BI 706321 Capsules n=6 Participants Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 15 mg BI 706321 Capsules Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 25 mg BI 706321 Capsules Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.
Part I: Time From Dosing to the Maximum Measured Concentration of BI 706321 in Plasma (Tmax)	5.61 hours Geometric Coefficient of Variation 16.7	5.25 hours Geometric Coefficient of Variation 51.6	5.22 hours Geometric Coefficient of Variation 31.8	5.24 hours Geometric Coefficient of Variation 51.6	4.91 hours Geometric Coefficient of Variation 22.3	4.12 hours Geometric Coefficient of Variation 43.7	3.37 hours Geometric Coefficient of Variation 70.7	3.64 hours Geometric Coefficient of Variation 62.1	—	—

SECONDARY outcome

Timeframe: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 168 hours after drug administration.

Part II: Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

Outcome measures

Outcome measures
Measure	Part I - Placebo Oral Solution n=12 Participants Part I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 0.3 mg BI 706321 Oral Solution n=12 Participants Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 0.6 mg BI 706321 Oral Solution n=12 Participants Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 1.2 mg BI 706321 Oral Solution Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - Placebo Capsules Part I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 2 mg BI 706321 Capsules Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 4 mg BI 706321 Capsules Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 8 mg BI 706321 Capsules Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 15 mg BI 706321 Capsules Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 25 mg BI 706321 Capsules Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.
Part II: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	169 hour*nanomol/liter Geometric Coefficient of Variation 26.1	154 hour*nanomol/liter Geometric Coefficient of Variation 28.0	171 hour*nanomol/liter Geometric Coefficient of Variation 27.7	—	—	—	—	—	—	—

Deaths: 0 deaths

Total

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part I - Placebo Oral Solution n=6 participants at risk Part I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - Placebo Capsules n=9 participants at risk Part I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.	Part I - 0.3 mg BI 706321 Oral Solution n=6 participants at risk Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 0.6 mg BI 706321 Oral Solution n=6 participants at risk Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 1.2 mg BI 706321 Oral Solution n=5 participants at risk Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 2 mg BI 706321 Capsules n=6 participants at risk Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 4 mg BI 706321 Capsules n=6 participants at risk Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 8 mg BI 706321 Capsules n=6 participants at risk Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 15 mg BI 706321 Capsules n=5 participants at risk Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part I - 25 mg BI 706321 Capsules n=6 participants at risk Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part II - Test 1 (T1), Fasted, Tablets n=12 participants at risk Part II - Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Part II - Test 2 (T2), Fed, Tablets n=12 participants at risk Part II - Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast.	Part II - Reference (R), Fasted, Capsules n=12 participants at risk Part II - Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Placebo Total n=15 participants at risk All subjects treated with placebo oral solution or placebo capsules groups.	BI 706321 Total Part I n=46 participants at risk All subjects in Part I treated with BI 706321.	Total Part I n=61 participants at risk All subjects in Part I.	BI 706321 Total Part II n=12 participants at risk All subjects in Part II treated with BI 706321.	BI 706321 Total n=58 participants at risk All subjects in Part I and II treated with BI 706321.	Total n=73 participants at risk All subjects in Part I and II.
Eye disorders Photokeratitis	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	20.0% 1/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.2% 1/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.7% 1/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	11.1% 1/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	6.7% 1/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	11.1% 1/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	6.7% 1/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	8.3% 1/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	4.3% 2/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	3.3% 2/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	8.3% 1/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	5.2% 3/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	4.1% 3/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Gastrointestinal disorders Lip dry	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.2% 1/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.7% 1/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
General disorders Catheter site pain	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.2% 1/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.7% 1/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
General disorders Feeling cold	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.2% 1/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.7% 1/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
General disorders Pre-existing condition improved	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	8.3% 1/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	8.3% 1/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.7% 1/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
General disorders Puncture site reaction	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	20.0% 1/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.2% 1/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.7% 1/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	20.0% 1/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	4.3% 2/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	3.3% 2/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	3.4% 2/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.7% 2/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Infections and infestations Rhinitis	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.2% 1/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.7% 1/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Injury, poisoning and procedural complications Contusion	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.2% 1/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.7% 1/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Injury, poisoning and procedural complications Scar	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.2% 1/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.7% 1/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.2% 1/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.7% 1/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	11.1% 1/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	6.7% 1/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.2% 1/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	3.3% 2/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.7% 1/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.7% 2/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	6.7% 1/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Musculoskeletal and connective tissue disorders Myosclerosis	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.2% 1/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.7% 1/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.2% 1/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.7% 1/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Nervous system disorders Dizziness	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	20.0% 1/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.2% 1/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.7% 1/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Nervous system disorders Headache	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	20.0% 1/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	8.3% 1/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	8.3% 1/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	6.7% 1/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.2% 1/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	3.3% 2/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	8.3% 1/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	3.4% 2/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	4.1% 3/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Nervous system disorders Presyncope	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	8.3% 1/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	8.3% 1/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.7% 1/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.2% 1/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.7% 1/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	2.2% 1/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.7% 1/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Vascular disorders Haematoma	16.7% 1/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/9 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/5 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/6 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	6.7% 1/15 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/46 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.6% 1/61 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/12 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	0.00% 0/58 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.	1.4% 1/73 • Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days. Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place