Trial Outcomes & Findings for A Trial in Healthy Chinese Volunteers to Test How Different Doses of BI 655130 Are Taken up in the Body (NCT NCT04390568)

NCT ID: NCT04390568

Last Updated: 2023-08-07

Results Overview

Area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. The time frames differed slightly between intravenous (IV) and subcutaneous (SC) administration. The prefix 'IV' indicates when IV was measured only. The prefix 'SC' indicates when SC was measured only. No prefix means that measurement time points were identical for IV and SC administration.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 50 participants
• Primary outcome timeframe: Within 3 hours (h) before drug administration and SC: 30 minutes (min), IV: 1h 30 min, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h, 2184h, 2856h, 3528h, 4200h after drug administration.
• Results posted on: 2023-08-07

Participant Flow

This was an open-label parallel-group design for intravenous (IV) and subcutaneous (SC) single-dose administration of Spesolimap (BI 655130) in healthy Chinese male and female subjects. Three cohorts were dosed consecutively in ascending order within the IV and two cohorts within the SC dose groups.

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

Measure	Spesolimap (BI 655130) - 450 Milligram (mg) - Intravenous (IV) A single dose of 450 mg Spesolimap was administered as solution for infusion intravenously over 90 minutes (mins) after an overnight fast.	Spesolimap - 900 mg - IV A single dose of 900 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.	Spesolimap - 1200 mg - IV A single dose of 1200 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.	Spesolimap - 300 mg - Subcutaneous (SC) A single dose of 300 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 seconds (s) after an overnight fast.	Spesolimap - 600 mg - SC A single dose of 600 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 s after an overnight fast.
Overall Study STARTED	10	10	10	10	10
Overall Study Treated	10	10	10	10	10
Overall Study COMPLETED	10	10	10	10	10
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial in Healthy Chinese Volunteers to Test How Different Doses of BI 655130 Are Taken up in the Body

Baseline characteristics by cohort

Measure	Spesolimap (BI 655130) - 450 Milligram (mg) - Intravenous (IV) n=10 Participants A single dose of 450 mg Spesolimap was administered as solution for infusion intravenously over 90 minutes (mins) after an overnight fast.	Spesolimap - 900 mg - IV n=10 Participants A single dose of 900 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.	Spesolimap - 1200 mg - IV n=10 Participants A single dose of 1200 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.	Spesolimap - 300 mg - Subcutaneous (SC) n=10 Participants A single dose of 300 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 seconds (s) after an overnight fast.	Spesolimap - 600 mg - SC n=10 Participants A single dose of 600 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 s after an overnight fast.	Total n=50 Participants Total of all reporting groups
Age, Continuous	29.0 Years STANDARD_DEVIATION 5.8 • n=5 Participants	31.0 Years STANDARD_DEVIATION 7.8 • n=7 Participants	34.6 Years STANDARD_DEVIATION 5.5 • n=5 Participants	31.5 Years STANDARD_DEVIATION 6.5 • n=4 Participants	30.5 Years STANDARD_DEVIATION 6.9 • n=21 Participants	31.3 Years STANDARD_DEVIATION 6.5 • n=10 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	20 Participants n=10 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	30 Participants n=10 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=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	50 Participants n=10 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=10 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=10 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	50 Participants n=10 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=10 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=10 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 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=10 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=10 Participants

PRIMARY outcome

Timeframe: Within 3 hours (h) before drug administration and SC: 30 minutes (min), IV: 1h 30 min, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h, 2184h, 2856h, 3528h, 4200h after drug administration.

Population: PK parameter analysis set (PKS): This set included all participants in the treated (TS) who provided at least one primary pharmacokinetic (PK) endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. PK data from replaced participants was expected to be not evaluable and thus replaced participants were not part of the PKS. One participant (900 mg IV group) missed the last measurement time point and was removed from the analyses.

Area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.

The time frames differed slightly between intravenous (IV) and subcutaneous (SC) administration. The prefix 'IV' indicates when IV was measured only. The prefix 'SC' indicates when SC was measured only. No prefix means that measurement time points were identical for IV and SC administration.

Outcome measures

Measure	Spesolimap (BI 655130) - 450 Milligram (mg) - Intravenous (IV) n=10 Participants A single dose of 450 mg Spesolimap was administered as solution for infusion intravenously over 90 minutes (mins) after an overnight fast.	Spesolimap - 900 mg - IV n=9 Participants A single dose of 900 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.	Spesolimap - 1200 mg - IV n=10 Participants A single dose of 1200 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.	Spesolimap - 300 mg - Subcutaneous (SC) n=10 Participants A single dose of 300 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 seconds (s) after an overnight fast.	Spesolimap - 600 mg - SC n=10 Participants A single dose of 600 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 s after an overnight fast.
Area Under the Concentration-time Curve of Spesolimap in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	3380 Day times microgram per milliliter Geometric Coefficient of Variation 17.5	6960 Day times microgram per milliliter Geometric Coefficient of Variation 19.2	10300 Day times microgram per milliliter Geometric Coefficient of Variation 21.1	1580 Day times microgram per milliliter Geometric Coefficient of Variation 22.2	3260 Day times microgram per milliliter Geometric Coefficient of Variation 34.1

PRIMARY outcome

Timeframe: Within 3 hours (h) before drug administration and SC: 30 minutes (min), IV: 1h 30 min, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h, 2184h, 2856h, 3528h, 4200h after drug administration.

Population: PK parameter analysis set (PKS): This set included all participants in the treated (TS) who provided at least one primary pharmacokinetic (PK) endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. PK data from replaced participants was expected to be not evaluable and thus replaced participants were not part of the PKS.

Maximum measured concentration of the Spesolimap in plasma (Cmax) The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.

Area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-8).

The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.

The time frames differed slightly between intravenous (IV) and subcutaneous (SC) administration. The prefix 'IV' indicates when IV was measured only. The prefix 'SC' indicates when SC was measured only. No prefix means that measurement time points were identical for IV and SC administration.

Outcome measures

Measure	Spesolimap (BI 655130) - 450 Milligram (mg) - Intravenous (IV) n=10 Participants A single dose of 450 mg Spesolimap was administered as solution for infusion intravenously over 90 minutes (mins) after an overnight fast.	Spesolimap - 900 mg - IV n=10 Participants A single dose of 900 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.	Spesolimap - 1200 mg - IV n=10 Participants A single dose of 1200 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.	Spesolimap - 300 mg - Subcutaneous (SC) n=10 Participants A single dose of 300 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 seconds (s) after an overnight fast.	Spesolimap - 600 mg - SC n=10 Participants A single dose of 600 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 s after an overnight fast.
Maximum Measured Concentration of the Spesolimap in Plasma (Cmax)	176 Microgram per milliliter Geometric Coefficient of Variation 12.5	370 Microgram per milliliter Geometric Coefficient of Variation 15.1	504 Microgram per milliliter Geometric Coefficient of Variation 17.3	32.0 Microgram per milliliter Geometric Coefficient of Variation 16.8	69.2 Microgram per milliliter Geometric Coefficient of Variation 35.7

SECONDARY outcome

Timeframe: Frome day of drug administration until 16 weeks thereafter, up to 16 weeks.

Population: Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.

Number of participants with treatment-emergent AEs.

All AEs occurring between first drug administration until 16 weeks thereafter were assigned to the randomised treatment.

Outcome measures

Measure	Spesolimap (BI 655130) - 450 Milligram (mg) - Intravenous (IV) n=10 Participants A single dose of 450 mg Spesolimap was administered as solution for infusion intravenously over 90 minutes (mins) after an overnight fast.	Spesolimap - 900 mg - IV n=10 Participants A single dose of 900 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.	Spesolimap - 1200 mg - IV n=10 Participants A single dose of 1200 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.	Spesolimap - 300 mg - Subcutaneous (SC) n=10 Participants A single dose of 300 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 seconds (s) after an overnight fast.	Spesolimap - 600 mg - SC n=10 Participants A single dose of 600 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 s after an overnight fast.
Number of Participants With Treatment-emergent Adverse Events (AE)s	8 Participants	9 Participants	8 Participants	7 Participants	9 Participants

SECONDARY outcome

Timeframe: Frome day of drug administration until 16 weeks thereafter, up to 16 weeks.

Population: Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.

Number of participants with drug-related AEs.

All AEs occurring between first drug administration until 16 weeks thereafter were assigned to the randomised treatment.

Outcome measures

Measure	Spesolimap (BI 655130) - 450 Milligram (mg) - Intravenous (IV) n=10 Participants A single dose of 450 mg Spesolimap was administered as solution for infusion intravenously over 90 minutes (mins) after an overnight fast.	Spesolimap - 900 mg - IV n=10 Participants A single dose of 900 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.	Spesolimap - 1200 mg - IV n=10 Participants A single dose of 1200 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.	Spesolimap - 300 mg - Subcutaneous (SC) n=10 Participants A single dose of 300 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 seconds (s) after an overnight fast.	Spesolimap - 600 mg - SC n=10 Participants A single dose of 600 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 s after an overnight fast.
Number of Participants With Drug-related Adverse Events (AEs).	4 Participants	8 Participants	4 Participants	4 Participants	7 Participants

Adverse Events

Spesolimap (BI 655130) - 450 Milligram (mg) - Intravenous (IV)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Spesolimap - 900 mg - IV

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Spesolimap - 1200 mg - IV

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Spesolimap - 300 mg - Subcutaneous (SC)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Spesolimap - 600 mg - SC

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Spesolimap (BI 655130) - 450 Milligram (mg) - Intravenous (IV) n=10 participants at risk A single dose of 450 mg Spesolimap was administered as solution for infusion intravenously over 90 minutes (mins) after an overnight fast.	Spesolimap - 900 mg - IV n=10 participants at risk A single dose of 900 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.	Spesolimap - 1200 mg - IV n=10 participants at risk A single dose of 1200 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.	Spesolimap - 300 mg - Subcutaneous (SC) n=10 participants at risk A single dose of 300 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 seconds (s) after an overnight fast.	Spesolimap - 600 mg - SC n=10 participants at risk A single dose of 600 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 s after an overnight fast.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.

Other adverse events

Measure	Spesolimap (BI 655130) - 450 Milligram (mg) - Intravenous (IV) n=10 participants at risk A single dose of 450 mg Spesolimap was administered as solution for infusion intravenously over 90 minutes (mins) after an overnight fast.	Spesolimap - 900 mg - IV n=10 participants at risk A single dose of 900 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.	Spesolimap - 1200 mg - IV n=10 participants at risk A single dose of 1200 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.	Spesolimap - 300 mg - Subcutaneous (SC) n=10 participants at risk A single dose of 300 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 seconds (s) after an overnight fast.	Spesolimap - 600 mg - SC n=10 participants at risk A single dose of 600 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 s after an overnight fast.
Blood and lymphatic system disorders Anaemia	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Gastrointestinal disorders Gingival pain	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	20.0% 2/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Gastrointestinal disorders Gingival swelling	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Gastrointestinal disorders Mouth ulceration	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Gastrointestinal disorders Nausea	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
General disorders Asthenia	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
General disorders Chills	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
General disorders Injection site erythema	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
General disorders Injection site haemorrhage	20.0% 2/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Infections and infestations Acne pustular	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Infections and infestations Folliculitis	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Infections and infestations Herpes virus infection	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Infections and infestations Oral herpes	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Infections and infestations Rhinitis	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Infections and infestations Tonsillitis	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Infections and infestations Upper respiratory tract infection	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	50.0% 5/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	40.0% 4/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Alanine aminotransferase increased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Bilirubin conjugated increased	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Blood bilirubin increased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Blood creatine phosphokinase increased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Blood fibrinogen decreased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	20.0% 2/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Blood glucose increased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Blood pressure decreased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	20.0% 2/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Blood pressure increased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Blood triglycerides increased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	20.0% 2/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations C-reactive protein increased	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Eosinophil percentage increased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Gamma-glutamyltransferase increased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Haemoglobin decreased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Heart rate decreased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Hepatic enzyme increased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations International normalised ratio increased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Lymphocyte count decreased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Neutrophil count decreased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Neutrophil count increased	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	20.0% 2/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	20.0% 2/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Protein urine present	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	20.0% 2/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Red blood cell count decreased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Red blood cell count increased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Reticulocyte count decreased	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Reticulocyte percentage increased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Urine leukocyte esterase positive	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations Urobilinogen urine increased	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations White blood cell count decreased	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Investigations White blood cells urine positive	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	20.0% 2/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Nervous system disorders Dizziness	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Nervous system disorders Headache	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Psychiatric disorders Insomnia	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Rhinalgia	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Skin and subcutaneous tissue disorders Acne	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Skin and subcutaneous tissue disorders Acne cystic	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	10.0% 1/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.	0.00% 0/10 • Adverse events: From the single drug administration till the end of the residual effect period, up to 113 days. All-Cause Mortality: From the single drug administration till the end of trial, up to 179 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treatment assignment was determined based on the (first) treatment the subjects received. The treated set was used for safety analyses.

Additional Information

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